Drug recall: Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC…

Nationwide within the United States

Astral SteriTech Private Ltd., Vadodara, N/A, India.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Drug events that started in 2023

281

Share of these events in Class II

59%

Product records in this event

52

Events of the firm on the register

1

• FDA enforcement report D-0580-2023The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: Nationwide within the United States

What quantity of product is in FDA event 92341?

The event has 52 product records. The first record gives this quantity: 70,040 vials

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2023 have the same class?

59% of the 281 drug events that started in 2023 are in Class II.