Tri-Coast Pharmacy Recalls Sermorelin Acetate Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 260 vials of Sermorelin Acetate 6 mg compounded between May and November 2016 because the agency cannot assure the products are sterile.
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. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are Severe; while no injuries are explicitly reported here, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe classification for Class II recalls where risk is present but not yet confirmed as Critical (Class I).
Plain-English summary
Tri-Coast Pharmacy is recalling 260 vials of Sermorelin Acetate 6 mg. The recall covers all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The agency has classified this as a Class II recall.
The reason for the recall is a lack of assurance of sterility. The source text does not specify the exact cause of the sterility failure or report any specific illnesses or injuries associated with the use of these products.
The affected products were distributed nationwide. Consumers who possess these vials should stop using them and contact their healthcare provider or the pharmacy for further instructions. Specific lot codes identified in the recall include 06062016D (expiration date 12/03/2016) and 08022016A (expiration date 01/29/2017).
The recalled product
- Product
- Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 260
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 (1)
- 08022016A (01/29/2017).
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.
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