Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were 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, which corresponds to a Severe rating under the rubric for drug recalls involving potential health risks.
Plain-English summary
Tri-Coast Pharmacy is recalling 18 vials of TriMix, a compounded medication containing Alprostadil, Phentolamine, and Papaverine. The recall is being conducted because there is a lack of assurance that the sterile products were properly sterilized during the compounding process.
The recall covers all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes with expiration dates are 06152016D (07/17/2016), 07272016D (09/08/2016), 10252016I (12/09/2016), 10172016A (11/24/2016), and 10202016A (11/24/2016). The products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 18
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 (4)
- 07272016D (09/08/2016)
- 10252016I (12/09/2016)
- 10172016A (11/24/2016)
- 10202016A (11/24/2016).
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 →Related recalls
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