Recalls / Class III
Class IIID-0481-2024
Product
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
- Brand name
- Valacyclovir Hydrochloride
- Generic name
- Valacyclovir
- Active ingredient
- Valacyclovir Hydrochloride
- Route
- Oral
- NDCs
- 0378-4275, 0378-4276
- FDA application
- ANDA078518
- Affected lot / code info
- Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
Why it was recalled
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Recalling firm
- Firm
- Viatris Inc
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 143,230 bottles
- Distribution pattern
- Nationwide within the united states
Timeline
- Recall initiated
- 2024-04-25
- FDA classified
- 2024-05-02
- Posted by FDA
- 2024-05-08
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0481-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.