Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #1 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #1 because FDA inspections found violations that may affect sterility.
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, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as sterility issues) are rated as Severe (4).
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of SUPER TRI-MIX #1, a prescription-only medication packaged in 5mL vials. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected products are distributed in Nevada and include specific lots with expiration dates ranging from April 2016 to July 2016. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased or been prescribed this product should contact their healthcare provider or the pharmacy for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- Hazard
- Affected units
- 869
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 (10)
- Lot #: 01062016:29@49
- Exp.04/06/2016
- Lot #: 02032016: 30@5
- Exp.05/03/2016
- Lot #: 03312016:91@17
- Exp. 06/29/2016
- Lot #: 03302016:17@40
- Exp. 06/30/2016
- Lot 4132016:46@20
- Exp. 07/12/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding 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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