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Recall Observatory FDA recall evidence

Drug product

Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)

D-0165-2023

December 20, 2022

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 91416
Status
Terminated
Classification
Class II
Quantity
3,091 cartons
Official record key
drug-enforcement:D-0165-2023

Official wording

Reason: Failed Impurities/Degradations Specifications

Code information: Lot #: 1007805, exp. 12/31/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Impurities/Degradations Specifications