Drug 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
D-1542-2022
Product summary
- Firm
- Viatris Inc
- Event
- Event 90886
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,931 cartons
- Official record key
drug-enforcement:D-1542-2022
Official wording
Reason: Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Code information: Lot 7105130, exp 9/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter