Nandrolone Decanoate Injectable Vials Recalled for Lack of Sterility Assurance
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
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: FDA Class II recall for injectable medication lacking sterility assurance. The source text does not report illnesses or injuries. However, non-sterile injectable medication constitutes a high-risk-of-harm product, justifying High severity per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 243 vials of Nandrolone Decanoate 200mg/mL injectable medication in both 5 mL and 10 mL vial sizes. The recall was issued due to a lack of assurance of sterility, meaning the manufacturer cannot confirm the product was produced under conditions ensuring it is free from viable microorganisms.
The affected vials were distributed nationwide throughout the USA and Puerto Rico. The recalled batches are: 10272107A1 (5 mL vials, expiration 4/25/2022), 12072130A1 (5 mL vials, expiration 6/5/2022), and 01032230A1 (10 mL vials, expiration 7/2/2022).
Injectable medications that lack sterility assurance pose a risk of serious infection. Consumers or patients in possession of these vials should not use the product and should contact their pharmacist or healthcare provider for guidance. Those who have already received injections from these vials should consult their healthcare provider about potential risks.
The recalled product
- Product
- Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Hazard
- sterility-failure
- contamination
- infection-risk
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 (6)
- Batch#: a) 10272107A1
- Exp 4/25/2022
- 12072130A1
- Exp 6/5/2022
- b) 01032230A1
- Exp 7/2/2022.
Distribution
Distributed nationwide across the United States.
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