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Serious recall: Injury is possible or has been reported. Take action promptly.

SUN PHARMACEUTICAL INDUSTRIES INC 2022-06-29 Health serious FDA
Health · FDA · Recall #FDA-D-1153-2022

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx… Recall

Issued June 29, 2022 · SUN PHARMACEUTICAL INDUSTRIES INC

In June 2022, SUN PHARMACEUTICAL INDUSTRIES INC recalled the Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

What you should do

  1. 1 Stop using Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact SUN PHARMACEUTICAL INDUSTRIES INC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Health
Recall date
June 29, 2022
Units affected
Not reported
Sold at
Nationwide in the USA and Puerto Rico
Recall number
FDA-D-1153-2022
Made in
United States
Issuing agency
FDA

In context

  • SUN PHARMACEUTICAL INDUSTRIES INC has 34 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 870th Health recall we've logged in 2022.
Read the official FDA notice

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