September 2022 FDA Recall Drug by Viatris Inc
D-1542-2022 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Viatris Inc on September 21, 2022 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1542-2022
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
09-21-2022
10-05-2022
3,931 cartons
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.
Viatris 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.
Nationwide in the USA
10-31-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
Batch or Lot Expiration Information
Lot# Lot 7105130, exp 9/2023
