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Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-32...

FDA Recall #D-0100-2021 — Class III — November 11, 2020

Recall #D-0100-2021 Date: November 11, 2020 Classification: Class III Status: Terminated

Product Description

Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.

Reason for Recall

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

Recalling Firm

Teva Pharmaceuticals USA — Parsippany, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

12,088 cartons

Distribution

Product was distributed Nationwide in the USA.

Code Information

Lot Number: 1351104, Exp 08/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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