Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampul
Summary
The FDA issued a Class II for Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water fo by Viatris Inc. Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity cha.
Details
Source
Drug Recall
External ID
D-0866-2023
Action Date
2023-06-14
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 101241A, Exp 10/23
Quantity Affected: 2,736 boxes
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.
Distribution
Product was distributed to 10 distributors who may have further distribute the product to the retail level.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
Company
Canonsburg, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Viatris Inc has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Viatris Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Viatris Inc have FDA actions?
Viatris Inc has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0866-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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