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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3

D-1052-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
3824 bags
Official record key
drug-enforcement:D-1052-2023

Official wording

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

Code information: Lot: 17-270599, 17-270600, Exp. 7/17/2023; 17-270785, Exp. 7/19/2023; 17-270969, Exp. 7/23/2023; 17-271116, 17-271135, Exp. 7/25/2023; 17-271242, Exp. 7/26/2023; 17-271502, Exp. 7/31/2023; 17-271561, 17-271589, Exp. 8/1/2023; 17-271672, Exp. 8/2/2023; 17-271837, Exp. 8/6/2023; 17-272291, Exp. 8/14/2023; 17-272363, 17-272364, Exp. 8/15/2023; 17-272453, Exp. 8/16/2023; 17-272607, Exp. 8/20/2023; 17-272706, Exp. 8/21/2023; 17-273148, Exp. 8/29/2023; 17-273421, Exp. 9/3/2023; 17-273698, 17-273700, Exp. 9/6/2023; 17-273966, Exp. 9/11/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility