Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceutica
Summary
The FDA issued a Class III for Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets by Teva Pharmaceuticals USA, Inc. Reason: OOS for viscosity.
Details
Source
Drug Recall
External ID
D-0127-2024
Action Date
2023-12-06
Status
Terminated
Category
drug
Product Description
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0591-2926-30
Lot/Code Info: Lot #: 100029472, Exp. 2/29/2024
Reason for Recall
OOS for viscosity
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-10
Company
Parsippany, NJ
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 46 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 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 (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0127-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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