FDAClass IIAugust 9, 2023

PHENYLephrine in 0.9% sodium chloride recall: Sterility Concern

PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook…

Why was PHENYLephrine in 0.9% sodium chloride recalled?

Lack of assurance of sterility: Lack of validation data for sanitization cycles

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: 17-270449, 17-270450, 17-270453, 17-270462, 17-270465, 17-270466, 17-270494, 17-270495, 17-270502, 17-270541, Exp. 7/16/2023; 17-270582, 17-270585, 17-270587, 17-270592, 17-270593, 17-270598, 17-270610, 17-270611, 17-270612, Exp. 7/17/2023; 17-270900, 17-270902, 17-270906, 17-270907, 17-270908, 17-270909, 17-270953, 17-270955, 17-270991, 17-270993, Exp. 7/23/2023; 17-271047, 17-271048, 17-271050, 17-271053, Exp. 7/24/2023; 17-271344, 17-271349, 17-271355, 17-271356, 17-271405, 17-271406, Exp. 7/31/2023; 17-271478, 17-271479, 17-271480, 17-271484, 17-271495, 17-271500, Exp. 7/31/2023; 17-271744, 17-271763, Exp. 8/3/2023; 17-271838, 17-271851, Exp. 8/6/2023; 17-271871, 17-271873, 17-271886, 17-271887, 17-271892, 17-271899, 17-271900, 17-271901, 17-271902, Exp. 8/7/2023; 17-272067, 17-272068, 17-272069, 17-272095, Exp. 8/9/2023; 17-272102, 17-272141, 17-272142, Exp. 8/10/2023; 17-272205, 17-272235, 17-272237, 17-272240, 17-272242, Exp. 8/13/2023; 17-272307, 17-272308, Exp. 8/14/2023; 17-272391, 17-272392, 17-272395, Exp. 8/15/2023; 17-272472, Exp. 8/16/2023; 17-272538, Exp. 8/17/2023; 17-272558, 17-272560, 17-272564, 17-272593, 17-272594, 17-272618, 17-272619, 17-272651, 17-272653, 17-272680, Exp. 8/20/2023; 17-272697, 17-272727, 17-272729, Exp. 8/21/2023; 17-272775, 17-272791, 17-272820, 17-272821, Exp. 8/22/2023; 17-272904, 17-272918, 17-272919, 17-272920, 17-272921, 17-272929, Exp. 8/23/2023; 17-272930, 17-272974, 17-272993, 17-272994, 17-272995, 17-272996, Exp. 8/24/2023; 17-272999, 17-273003, 17-273004, 17-273005, 17-273006, 17-273007, Exp. 8/27/2023; 17-273080, Exp. 8/28/2023; 17-273151, 17-273175, 17-273176, 17-273185, Exp. 8/29/2023; 17-273252, 17-273265, 17-273266, Exp. 8/30/2023; 17-273345, 17-273351, 17-273352, 17-273355, 17-273356, 17-273358, 17-273359, 17-273360, Exp. 8/31/2023; 17-273402, 17-273408, 17-273416, 17-273440, 17-273441, 17-273447, Exp. 9/3/2023; 17-273487, 17-273488, 17-273489, 17-273490, 17-273491, 17-273499, 17-273510, 17-273516, Exp. 9/4/2023; 17-273587, 17-273589, 17-273596, 17-273597, 17-273610, 17-273614, 17-273666, Exp. 9/5/2023; 17-273617, 17-273665, 17-273703, 17-273704, 17-273713, 17-273714, 17-273720, 17-273721, 17-273730, 17-273737, 17-273739, Exp. 9/6/2023; 17-273773, Exp. 9/7/2023; 17-273802, 17-273803, 17-273808, 17-273809, 17-273815, 17-273848, 17-273869, 17-273874, 17-273880, 17-273881, 17-273893, Exp. 9/10/2023; 17-273903, 17-273958, 17-273960, 17-273961, 17-273964, 17-273965, Exp. 9/11/2023.

Product
PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook…
Recalling firm
Central Admixture Pharmacy Services Inc
Quantity
81,073 syringes
Distribution
Nationwide in the USA
Recall date
August 9, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls