Testosterone Injection Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential sterility issues in injectable products are categorized as Severe (Score 4) due to the risk of infection or serious injury, even without reported hospitalizations in the text.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 01122015@25 (7/11/2015), 02232015@48 (8/22/2015), and 03242015@27 (9/20/2015).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroids
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- All lots distributed between November 2014 and May 2015
- 01122015@25
- 7/11/2015
- 02232015@48
- 8/22/2015
- 03242015@27
- 9/20/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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