Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling TriMix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable product) is categorized as Severe (Score 4), particularly given the potential for serious infection from non-sterile injections.
Plain-English summary
Tri-Coast Pharmacy is recalling specific lots of TriMix, a compounded medication containing Alprostadil, Phentolamine, and Papaverine. The recall is being conducted due to a lack of assurance of sterility, meaning the products may not be sterile.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The source text identifies two known lot codes with expiration dates: 07152016C (expiring August 22, 2016) and 09292016A (expiring November 6, 2016). The affected products were distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the products are found, they should be discontinued and returned to the pharmacy or disposed of according to local regulations. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 9
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)
- 09292016A (11/06/2016).
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.
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