Agency classClass IIOur severity:High FDA (Drugs)·D-0600-2023·Announced 2023-05-24

Ampicillin and Sulbactam for Injection recalled nationwide for sterility assurance deficiency

Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.

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 drug recall initiated due to lack of sterility assurance in an injectable antibiotic. No illnesses or injuries have been reported. The potential hazard of infection from a non-sterile injectable is serious but unconfirmed, placing this in the High severity category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ampicillin and Sulbactam for Injection, USP (3 grams per vial), is being recalled nationwide. This is a prescription injectable antibiotic manufactured by Astral SteriTech Private Ltd. for Piramal Critical Care, located in Bethlehem, Pennsylvania. Approximately 91,860 vials are included in the recall and were distributed throughout the United States.

The recall was initiated due to lack of assurance of sterility. All lot numbers of the affected product are currently within their expiration dates.

Healthcare facilities, pharmacies, prescribers, and patients in possession of this product should immediately discontinue use and quarantine all affected vials. Contact the manufacturer or the U.S. Food and Drug Administration for guidance on replacement products and proper handling of recalled inventory.

The recalled product

Product: Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
Manufacturer: Astral SteriTech Private Ltd.
Category: Drug — Injectable Antibiotic
Hazard: lack-of-sterility
infection-risk
Affected units: 91,860

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 →

Same manufacturer · Astral SteriTech Private Ltd.

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Same hazard · lack of sterility