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Class II · ModerateRecall completed

Buprenorphine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc
Brand nameBUPRENORPHINE HYDROCHLORIDE
Generic nameBUPRENORPHINE HYDROCHLORIDE
Active ingredient(s)BUPRENORPHINE HYDROCHLORIDE
Distributed by / forHikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc
NDC0143-9246-01
Show the full FDA record
Full product labelBuprenorphine 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.
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide in the U.S.
Quantity97,890 vials
Recall initiated2020-08-14
Report date2020-09-02
Recall completed2021-06-10
Recall numberD-1533-2020
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.