Nandrolone Decanoate Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile injection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature. The recall involves 169 ml total volume 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. The specific hazard is a lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Nandrolone Decanoate 200 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 (20)
- All lots distributed between November 2014 and May 2015: 02272015@1
- 8/26/2015
- 12182015@67
- 6/16/2015
- 02062015@141
- 8/5/2015
- 04222015@13
- 9/29/2015
- 04072015@33
- 10/4/2015
- 04212015@13
- 10/18/2015
- 04082015@7
- 10/5/2015
- 04142015@24
- 10/11/2015
- 04272015@84
- 10/24/2015
- and 05082015@7
- 11/4/2015
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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