Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA,
Summary
The FDA issued a Class II for Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manuf by Astral SteriTech Private Ltd.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0589-2023
Action Date
2023-05-24
Status
Terminated
Category
drug
Product Description
Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
Lot/Code Info: All lots within expiry.
Quantity Affected: 7,214 bottles
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-15
Company
Vadodara, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 99 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Astral SteriTech Private Ltd. has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Astral SteriTech Private Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Astral SteriTech Private Ltd. have FDA actions?
Astral SteriTech Private Ltd. has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0589-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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