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.
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.
Lot numbers, UPCs & expiration codes
Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Where it was sold
The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0765-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 22, 2023
- FDA report date
- May 31, 2023
- Quantity
- 87,360 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0765-2023, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 92380
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
- Postal code
- 08520-1401
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0765-2023
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 87,360 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
- Recall initiation date
- May 22, 2023
- Initial firm notification
- Letter
- Center classification date
- May 24, 2023