The Recall Desk
HighFDA (Drugs)·D-0278-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Nandrolone Decanoate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml because the agency could not ensure the products were sterile.

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 (sterility failure) where no injuries have been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Tri-Coast Pharmacy is recalling 701 vials of Nandrolone Decanoate 200 mg/ml (5 ML) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016.

The affected products were distributed nationwide. Specific lot codes included in the recall are 07112016A, 08172016B, 09122016C, and 10252016E. The source text does not report any illnesses or injuries associated with these products.

Consumers should check their inventory for these specific lot codes and dates. If they possess the recalled items, they should stop using them and contact Tri-Coast Pharmacy or their healthcare provider for further instructions.

The recalled product

Product
Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Affected units
701

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)

  • 08172016B (2/13/2017)
  • 09122016C (02/28/2017)
  • 10252016E (02/28/2017).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 80 recalled by Tri-Coast Pharmacy 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.

See all 80 products in this recall →