The Recall Desk
HighFDA (Drugs)·D-0580-2023·Announced 2023-05-24

Ampicillin for Injection Recall Due to Sterility Assurance Concerns

Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.

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 is an FDA Class II recall with no reported illnesses or injuries. The hazard—lack of assurance of sterility—is theoretical and preventive in nature. Per the severity rubric, recalls with theoretical, unconfirmed hazards and no reported harm are rated High (3).

Plain-English summary

Astral SteriTech Private Ltd. is recalling 70,040 vials of Ampicillin for Injection, USP 250 mg per vial (NDC 66794-220-41), manufactured for Piramal Critical Care. The recall was initiated due to lack of assurance of sterility.

Sterility is a critical quality attribute for injectable medications. An injectable product that is not sterile could introduce bacteria or other microorganisms into the bloodstream. All affected lots remain within their expiration dates.

The recalled product was distributed nationwide within the United States. Healthcare providers and patients who have received or possess this medication should consult with their healthcare provider or pharmacist regarding appropriate action.

Consumers with questions or who believe they have received the recalled product should contact their healthcare provider, pharmacist, or the manufacturer. Healthcare facilities should verify whether they received the recalled lots and quarantine any affected inventory.

The recalled product

Product
Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
Manufacturer
Astral SteriTech Private Ltd.
Category
Drug — Injectable Antibiotic
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