Why it was recalled
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Product description
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Lot numbers, UPCs & expiration codes
Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
Where it was sold
CA and NV
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-0647-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 8, 2024
- FDA report date
- Sep 4, 2024
- Quantity
- 266 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0647-2024, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95132
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
- Postal code
- 92807-1801
- Report date
- Sep 4, 2024
- Product type
- Drugs
- Recall number
- D-0647-2024
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 266 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications - at 18-month Stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
- Distribution pattern
- CA and NV
- Recall initiation date
- Aug 8, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2024