Well Care Compounding Pharmacy Recalls TRI-MIX # 4 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling 869 vials of TRI-MIX # 4 in Nevada due to GMP violations that may impact 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, which corresponds to a Severe severity score under the rubric for potential serious health consequences.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of TRI-MIX # 4, packaged in 5 mL vials. The product is prescription-only and was distributed in Nevada. The specific lot number is 03022016:16@45, with an expiration date of 06/01/2016.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. This lack of assurance of sterility poses a risk to patients using the medication.
Consumers who have purchased this specific lot of TRI-MIX # 4 should stop using it immediately and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- TRI-MIX # 4, packaged in 5 mL 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 (2)
- Lot #: 03022016:16@45
- Exp. 06/01/2016
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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