Why it was recalled
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Product description
Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
Lot numbers, UPCs & expiration codes
Lot #: 179643, Exp. Date 08/31/2023.
Where it was sold
Distributed to one wholesaler in AL for further distribution in the US.
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-1188-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 17, 2022
- FDA report date
- Jul 20, 2022
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bryant Ranch Prepack, Inc.
Original FDA data
Every field from FDA enforcement report D-1188-2022, exactly as published.
Show all FDA fields
- City
- Burbank
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 90481
- Address
- 1919 N Victory Pl
- Code information
- Lot #: 179643, Exp. Date 08/31/2023.
- Postal code
- 91504-3425
- Report date
- Jul 20, 2022
- Product type
- Drugs
- Recall number
- D-1188-2022
- Classification
- Class I
- Recalling firm
- Bryant Ranch Prepack, Inc.
- Termination date
- Apr 2, 2024
- Reason for recall
- Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
- Distribution pattern
- Distributed to one wholesaler in AL for further distribution in the US.
- Recall initiation date
- Jun 17, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2022