The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0866-2023·Announced 2023-06-14

Levsin injection recalled for manufacturing quality program discontinuation

Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate, 0.5 mg/ml) due to discontinuation of the quality assurance program that verifies product identity, strength, quality, and purity. The recall affects 2,736 boxes distributed to 10 distributors.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves a risk-of-harm product (injectable pharmaceutical) where the manufacturer's quality assurance program has been discontinued. The CGMP deviation affects the product's ability to assure identity, strength, quality, and purity characteristics, warranting High severity per the rubric for risk-of-harm products.

Plain-English summary

Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate injection, USP, 0.5 mg per ml) because the manufacturer discontinued its quality assurance program. This program normally ensures the product meets the identity, strength, quality, and purity characteristics it is supposed to possess.

The affected product consists of 1 ml ampules supplied in boxes of 5, with lot number 101241A and expiration date October 2023. Approximately 2,736 boxes were distributed to 10 distributors who may have further distributed the product to retail locations.

The FDA has classified this as a Class II recall. The discontinuation of the quality program constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The recalled product

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
Manufacturer
Viatris Inc
Category
Drug
Hazard
Affected units
2,736

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 101241A
  • Exp 10/23

Distribution

Distribution scope not specified by the agency.

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