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
Reported: November 15, 2023 Initiated: November 9, 2021 #D-0087-2024
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
Reason for Recall
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Details
- Recalling Firm
- PAR Sterile Products LLC
- Distribution
- Nationwide USA
- Location
- Rochester, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by PAR Sterile Products LLC.
Why was this product recalled? ▼
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0087-2024.
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