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.
D-0765-2023
Product summary
- Event
- Event 92380
- Status
- Completed
- Classification
- Class II
- Quantity
- 87,360 bottles
- Official record key
drug-enforcement:D-0765-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Code information: Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Distribution pattern: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
out of specification