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Class II: temporary or reversible health riskTerminated

Viatris Ampicillin for Injection Recall

Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vial…

Viatris Inc · Canonsburg, PA

Risk level
Class II
Reported by FDA
Oct 5, 2022
Recall ID
D-1542-2022
Check your lot numberHow we source this data

Summary

Viatris recalled Ampicillin for Injection starting Sep 21, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1542-2022 on Oct 5, 2022. Reason: Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot 7105130, exp 9/2023

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1542-2022
Classification
Class II
Status
Terminated
Recall initiated
Sep 21, 2022
FDA report date
Oct 5, 2022
Quantity
3,931 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Viatris Inc

Original FDA data

Every field from FDA enforcement report D-1542-2022, exactly as published.

Show all FDA fields
City
Canonsburg
State
PA
Status
Terminated
Country
United States
Event ID
90886
Address
1000 Mylan Blvd
Code information
Lot 7105130, exp 9/2023
Postal code
15317-5853
Report date
Oct 5, 2022
Product type
Drugs
Recall number
D-1542-2022
Classification
Class II
Recalling firm
Viatris Inc
Product quantity
3,931 cartons
Termination date
Oct 31, 2023
Reason for recall
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Sep 21, 2022
Initial firm notification
Letter
Center classification date
Sep 23, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1542-2022, published Oct 5, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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