May 2023 FDA Recall Drug by Viatris Inc
D-0866-2023 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Viatris Inc on May 25, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 10 distributors who may have further distribute the product to the retail level. and the recall is currently terminated.

Recall Number: D-0866-2023

Reason for Recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Initiated
05-25-2023
Reported
06-14-2023
Quantity
2,736 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92366
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.
Viatris 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.
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-11-2024
Product Description About Product Description
Full technical description of the product.
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

Batch or Lot Expiration Information

Lot# : 101241A, Exp 10/23