The Recall Desk
HighFDA (Drugs)·D-0604-2023·Announced 2023-05-24

Cefepime for Injection Recalled Due to Lack of Sterility Assurance

Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.

What this means for you

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 recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.' Lack of sterility assurance in injectable medications presents significant potential harm, but no illnesses or injuries are mentioned in the source text.

Plain-English summary

Astral SteriTech Private Ltd. is recalling all lots of Cefepime for Injection, USP 1 gram per vial (101,550 vials total) distributed nationwide in the United States. The product is manufactured for Civica Inc. and carries NDC 72572-057-10.

The recall was initiated due to lack of assurance of sterility. Sterility is critical for injectable medications, as non-sterile products could introduce harmful microorganisms into patients. All affected lots remain within their expiration dates.

Patients who have received this medication should contact their healthcare provider immediately for guidance. Healthcare facilities should remove affected vials from inventory and follow recall instructions for proper handling and return.

The recalled product

Product
Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Antibiotic Injection
Hazard
  • lack-of-sterility

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.

Related recalls

Same category