Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Heal
Summary
The FDA issued a Class III for Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Pa by American Health Packaging. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0813-2021
Action Date
2021-09-29
Status
Terminated
Category
drug
Product Description
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Lot/Code Info: Lot #: 1000789, Exp. Date 10/31/2022
Quantity Affected: 290 cartons
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-12
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 42 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
American Health Packaging has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (American Health Packaging) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Health Packaging have FDA actions?
American Health Packaging has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0813-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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