Why it was recalled
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Product description
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Lot numbers, UPCs & expiration codes
Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Where it was sold
Nationwide in the U.S.
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-1533-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 14, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 97,890 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-1533-2020, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86243
- Address
- 2 Esterbrook Ln
- Code information
- Lot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
- Postal code
- 08003-4002
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1533-2020
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 97,890 vials
- Termination date
- Jun 10, 2021
- Reason for recall
- Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Aug 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2020