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Recall Observatory FDA recall evidence

Drug product

dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.

D-0713-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
3040 bags
Official record key
drug-enforcement:D-0713-2023

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 # 37-896374, 37-896375, Exp 05/31/2023; 37-896876, 37-896878, Exp 06/02/2023; 37-897077, 37-897078, Exp 06/05/2023; 37-900074, 37-900075, 37-900076, 37-900111, 37-900112, 37-900115, Exp 06/15/2023; 37-900328, Exp 06/16/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility