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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.

D-0733-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
13953 bags
Official record key
drug-enforcement:D-0733-2023

Official wording

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/2023; 37-884749, 37-884751, Exp 05/05/2023; 37-885338, Exp 05/08/2023; 37-885756, Exp 05/09/2023; 37-886272, Exp 05/11/2023; 37-887512, Exp 05/16/2023; 37-888027, 37-888030, 37-888040, 37-888052, 37-888063, Exp 05/18/2023; 37-888314, Exp 05/21/2023; 37-890489, 37-890497, 37-890534, Exp 05/29/2023; 37-890933, Exp 05/30/2023; 37-891152, Exp 05/31/2023; 37-892985, 37-892986, 37-892995, Exp 06/07/2023; 37-893511, 37-893517, Exp 06/11/2023; 37-896481, Exp 06/21/2023; 37-897828, Exp 06/27/2023; 37-898523, Exp 06/29/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility