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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.

D-0715-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
6407 bags
Official record key
drug-enforcement:D-0715-2023

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 # 37-884272, Exp 05/03/2023; 37-887513, Exp 05/16/2023; 37-888083, Exp 05/18/2023; 37-889123, 37-889423, Exp 05/23/2023; 37-891563, Exp 06/01/2023; 37-892577, 37-892582, Exp 06/06/2023; 37-893248, 37-893257, Exp 06/08/2023; 37-894436, Exp 06/13/2023; 37-895805, Exp 06/19/2023; 37-898324, Exp 06/28/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility