Multi-event May 2024 FDA Recall Buprenorphine Hydrochloride by Pfizer Inc.
This Multi-event Class II drug recall was voluntarily initiated by Pfizer Inc. on May 20, 2024 for the product Buprenorphine Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility-the potential for incomplete crimp seals.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0565-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
05-20-2024
07-03-2024
220,400 cartridges
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide and Puerto Rico.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Batch or Lot Expiration Information
Lot# : HJ7566; Exp 2025/05
Lot# : HN8747; Exp 2025/09
Lot# : HN8749; Exp 2025/09
Affected Packages Involved in this Recall
Recall Number: D-0564-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
05-20-2024
07-03-2024
84,710 cartridges
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pfizer Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide and Puerto Rico.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03
Batch or Lot Expiration Information
Lot# : HJ3965; Exp 2024/09
Lot# : HJ8546; Exp 2024/10
