Why it was recalled
Crystallization; identified as Buprenorphine free base
Product description
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Lot numbers, UPCs & expiration codes
Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
Where it was sold
Nationwide 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-0087-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2021
- FDA report date
- Nov 15, 2023
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAR Sterile Products LLC
Original FDA data
Every field from FDA enforcement report D-0087-2024, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 89016
- Address
- 870 Parkdale Rd
- Code information
- Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023
- Postal code
- 48307-1740
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0087-2024
- Classification
- Class II
- Recalling firm
- PAR Sterile Products LLC
- Termination date
- Sep 29, 2024
- Reason for recall
- Crystallization; identified as Buprenorphine free base
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 4, 2023