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Class II · ModerateRecall completed

Levsin injection (hyoscyamine sulfate injection

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 101241A, Exp 10/23
Where it was soldProduct was distributed to 10 distributors who may have further distribute the product to the retail level.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forMeda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120
NDC0037-9001-05
Show the full FDA record
Full product labelLevsin 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
Recalling firmViatris Inc
DistributionProduct was distributed to 10 distributors who may have further distribute the product to the retail level.
Quantity2,736 boxes
Recall initiated2023-05-25
Report date2023-06-14
Recall completed2024-04-11
Recall numberD-0866-2023
ClassificationClass II
FDA statusTerminated
Origin on fileCanonsburg PA United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.