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Class II · ModerateRecall completed

Testosterone

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: 1403180, EXP. 10/2022
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Superpotent Drug: Out of specification assay result was obtained during stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byActavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet
Brand nameTESTOSTERONE
Generic nameTESTOSTERONE
Active ingredient(s)TESTOSTERONE
Distributed by / forActavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet
NDC0591-3216-17
Show the full FDA record
Full product labelTestosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Recalling firmTeva Pharmaceuticals USA Inc
DistributionNationwide in the USA
Quantity12354 cartons
Recall initiated2022-06-29
Report date2022-08-03
Recall completed2024-03-15
Recall numberD-1289-2022
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.