Reported Sep 2, 2020 · Terminated
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by:…
Hikma Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002
Is this the product you have?
- Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only
- Manufactured byHikma Farmaceutica, Portugal S.A
- Distributed byHikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc
- NDC0143-9246-01
- Lot codes and dates
Lot #s: 2005023.12005024.12005025.1Exp 02/28/2021
- Amount recalled
- 97,890 vials
Where it was sold
- Nationwide
Why it was recalled
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
This product could cause temporary or reversible health problems — stop using it.
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