Nandrolone Decanoate Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 250 mg/ml injections due to FDA-identified 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 and involves a lack of assurance of sterility in an injectable medication, which carries a significant risk of serious injury or death if the product is contaminated.
Plain-English summary
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature. The recall involves 24 ml total volume vials distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. This lack of assurance of sterility poses a risk to patients using the medication.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroid
- 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 (3)
- All lots distributed between November 2014 and May 2015
- 03092015@49
- 9/5/2015
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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