FDAClass IIIMay 7, 2014

Children's Triacting Night Time Cold & Cough with PE recall

Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.

Why was Children's Triacting Night Time Cold & Cough with PE recalled?

Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

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) 73825 (6/14), 74141 (6/14), 74830 (6/14), 74898 (7/14), 75339 (7/14), 75455 (7/14), 78531 (9/14), 79050 (9/14), 79267 (10/14), 80017 (7/14), 80781 (7/14), 81121 (10/14), 82178 (10/14). FAMILY wellness B) 82312 (10/14), 82500 (10/15), 133197 (1/15), 140385 (1/15), 141937 (2/15), 142669 (2/15), 143201 (2/15), 143656 (2/15), 145268 (2/15), 146058 (2/15), 146406 (2/15), 146963 (2/15), 147613 (3/15), 148105 (3/15), 148297 (7/15), 148809 (3/15), 149149 (8/15), 149317 (8/15), 149411 (8/15), 149814 (8/15), 149815 (8/15), 150305 (8/15), 150673 (8/15), 151039 (9/15), 151573 (9/15), 151762 (9/15), 152798 (9/15), 153206 (9/15), 153207 (9/15), 153514 (9/15), 154024 (9/15), 155380 (1/16). Good Neighbor Pharmacy C)141202 (2/15),145249 (2/15), 146425 (2/15). Pedia Care D) 73242 (5/14), 73243 (5/14), 73244 (5/14), 73824 (6/14), 74206 (6/14), 74207 (6/14), 74303 (6/14), 74460 (6/14), 78805 (9/14), 79265 (10/14), 79266 (10/14), 79573 (9/14), 80456 (6/14), 80457 (7/14), 83746 (1/15), 133196 (1/15), 144273 (2/15), 154090 (9/15). Quality Choice E) 79355 (6/14), 133193 (1/15), 149447 (8/15), 152870 (8/15). Safeway F) 74899 (7/14), 75103 (7/14), 78803 (9/14), 79089 (9/14), 79349 (6/14), 79671 (10/14), 80599 (10/14), 81263 (7/14), 81960 (10/14), 82047 (10/14), 83726 (1/15), 133194 (1/15), 140252 (1/15), 141023 (2/15), 141692 (2/15), 142148 (2/15), 142316 (2/15), 143399 (2/15), 145170 (2/15), 145826 (1/15), 145828 (1/15), 145829 (2/15), 147961 (3/15), 150302 (2/15), 150304 (7/15), 150549 (8/15), 150866 (9/15), 151650 (8/15), 151651 (9/15), 151906 (9/15), 154922 (1/16), 154923 (1/16). Well at Walgreens G) 73671 (5/14), 73898 (6/14), 74459 (6/14), 74900 (7/14), 75306 (7/14), 75671 (7/14), 76022 (7/14), 78804 (9/14), 79264 (5/14), 79325 (6/14), 79747 (6/14), 8188401 (7/14), 8195301 (7/14), 8195401 (9/14), 8195501 (10/14), 8200601 (10/14), 8257301 (10/14), 8282601 (10/14), 8374501 (10/14), 13319201 (1/16), 13319501 (1/16), 14096601 (2/15), 14165601 (2/15), 14193601 (2/15), 14726901 (3/15), 14755501 (3/15), 14812901 (3/15), 14824701 (3/15), 14829601 (7/15), 14914401 (8/15), 15074701 (9/15), 15434701 (11/15).

Product
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.
Recalling firm
P&L Developments, LLC
Quantity
1,363,338 Bottles
Distribution
Nationwide in US
Recall date
May 7, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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