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.
Reported: September 2, 2020 Initiated: August 14, 2020 #D-1533-2020
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.
Reason for Recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 97,890 vials
- Distribution
- Nationwide in the U.S.
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 97,890 vials.
Why was this product recalled? ▼
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2020. Severity: Moderate. Recall number: D-1533-2020.
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