September 2022 FDA Recall Aminophylline by Pfizer Inc.
D-0003-2023 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Pfizer Inc. on September 27, 2022 for the product Aminophylline. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in Distributed in the United States and Puerto Rico. and the recall is currently terminated.
Recall Number: D-0003-2023
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
09-27-2022
10-12-2022
103,150 10 mL vials
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.
Terminated
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.
Distributed in the United States and Puerto Rico.
08-21-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Batch or Lot Expiration Information
Lot# Lot: 30-137-DK Exp. 1 DEC. 2022
