Recalls / Class II
Class IID-0765-2023
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.
- Brand name
- Pain Reliever
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 0363-9947
- FDA application
- M013
- Affected lot / code info
- Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Why it was recalled
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- WALGREEN CO.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 87,360 bottles
- Distribution pattern
- The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2023-05-22
- FDA classified
- 2023-05-24
- Posted by FDA
- 2023-05-31
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0765-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.