Drug recall D-0765-2023

Class II Completed reported May 31, 2023

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.

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Aurobindo Pharma USA Inc., East Windsor, NJ
Quantity
87,360 bottles
Distribution
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
May 22, 2023

Related products