Drug Enforcement D-1542-2022

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

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Status

Terminated

Classification

Class II

Report Date

October 5, 2022

Termination Date

October 31, 2023

Product Information

Product description
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
Product quantity
3,931 cartons
Reason for recall
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1542-2022
Event ID
90886
Recall initiation date
September 21, 2022
Center classification date
September 23, 2022
Code info
Lot 7105130, exp 9/2023
More code info
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