Ampicillin for Injection Recalled Due to Foreign Object Contamination
Viatris Inc recalls 3,931 cartons of Ampicillin for Injection after a complaint of a hair strand found in one vial. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is low-risk contamination in a single vial with no reported illnesses or injuries. Although it involves a sterile injectable medication, the contaminant itself (a hair) poses minimal direct health risk, fitting the criteria for Moderate severity.
Plain-English summary
Viatris Inc is recalling 3,931 cartons of Ampicillin for Injection, USP, 2 grams/vial (NDC 67457-352-02) nationwide in the United States.
The recall was initiated after a complaint was received regarding the presence of a single strand of hair in one vial. The affected lot is 7105130 with an expiration date of September 2023. Ampicillin is an antibiotic used to treat bacterial infections.
This product was distributed nationwide. Patients who have received a vial from the affected lot should not use it and should contact their healthcare provider or pharmacist.
The recalled product
- 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
- Manufacturer
- Viatris Inc
- Category
- Drug — Antibiotic Injection
- Hazard
- Affected units
- 3,931
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 7105130
- exp 9/2023
Distribution
Distributed nationwide across the United States.
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