Viatris Inc 2023-06-14 Health serious FDA
Health · FDA · Recall #FDA-D-0866-2023
Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for… Recall
Issued June 14, 2023 · Viatris Inc
In June 2023, Viatris Inc recalled the Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Viatris Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Viatris Inc
- Category
- Health
- Recall date
- June 14, 2023
- Units affected
- Not reported
- Sold at
- Product was distributed to 10 distributors who may have further distribute the product to the retail level.
- Recall number
- FDA-D-0866-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Viatris Inc has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.