FDA recall D-1533-2020

Product

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.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2020-08-14

Report date

2020-09-02

Termination date

2021-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1533-2020