Recalls / Class II
Class IID-1542-2022
Product
Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
- Affected lot / code info
- Lot 7105130, exp 9/2023
Why it was recalled
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Recalling firm
- Firm
- Viatris Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, N/A, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 3,931 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-09-21
- FDA classified
- 2022-09-23
- Posted by FDA
- 2022-10-05
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1542-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.