FDA recall D-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

Reason for recall

Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-09-21

Report date

2022-10-05

Termination date

2023-10-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1542-2022