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Recall Observatory FDA recall evidence

Drug product

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

D-0765-2023

May 22, 2023

Class II

Product summary

Firm
Aurobindo Pharma USA Inc.
Event
Event 92380
Status
Completed
Classification
Class II
Quantity
87,360 bottles
Official record key
drug-enforcement:D-0765-2023

Official wording

Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

Code information: Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023

Distribution pattern: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification