Cefepime for Injection Recalled Due to Sterility Assurance Concerns
The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for lack of sterility assurance in an injectable medication. The hazard is theoretical—no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
The FDA is recalling Cefepime for Injection, USP 2 grams per vial (NDC 71288-009-20), manufactured by Astral SteriTech Private Ltd. for Meitheal Pharmaceuticals, Chicago, IL. The recall affects 107,320 vials distributed nationwide throughout the United States.
The FDA issued this Class II recall because the sterility of the product cannot be assured. Injectable medications that lack sterile assurance may pose a risk of infection. No illnesses or injuries related to this product have been reported to date.
If you have received this medication, do not use it. Contact your healthcare provider or pharmacist immediately for guidance. Return the medication to the pharmacy where it was obtained or contact the manufacturer for disposal instructions.
The recalled product
- Product
- Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable / Antibiotic
- Affected units
- 107,320
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 (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
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