D-0765-2023 Class II

Recalled by Aurobindo Pharma USA Inc. — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
May 31, 2023
Initiation Date
May 22, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
87,360 bottles

Product Description

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.

Distribution Pattern

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

Code Information

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