FDA recall D-0765-2023

Aurobindo Pharma USA Inc. · Class II · 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.

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

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

Key facts

Status
Completed
Initiation date
2023-05-22
Report date
2023-05-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2023