May 2023 FDA Recall Pain Reliever by Aurobindo Pharma Usa Inc.
D-0765-2023 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on May 22, 2023 for the product Pain Reliever. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0765-2023
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
05-22-2023
05-31-2023
87,360 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
