Recall record at a glance
| Official record | D-0765-2023 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Report date | May 31, 2023 |
| Recall initiation date | May 22, 2023 |
| Quantity | 87,360 bottles |
| Location | East Windsor, NJ, United States |
Official 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.
Why the product 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.
Distribution information
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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