FDAClass IIIApril 30, 2014

Day Time Cold & Flu recall: Subpotent

Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170

Why was Day Time Cold & Flu recalled?

Subpotent Drug: Phenylephrine component is subpotent.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).

Product
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170
Recalling firm
P&L Developments, LLC
Quantity
2,500,510 bottles
Distribution
Nationwide in US
Recall date
April 30, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls