August 2020 FDA Recall Buprenorphine Hydrochloride by Hikma Pharmaceuticals Usa Inc.
D-1533-2020 - Sub-potent Drug

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on August 14, 2020 for the product Buprenorphine Hydrochloride. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1533-2020

Reason for Recall
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Initiated
08-14-2020
Reported
09-02-2020
Quantity
97,890 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86243
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2021
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# s: 2005023.1, 2005024.1, 2005025.1, Exp 02/28/2021

Affected Packages Involved in this Recall

0143-9246-01 Buprenorphine Hydrochloride
0143-9246-05 Buprenorphine Hydrochloride