Well Care Compounding Pharmacy Recalls TRI-MIX # 1 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling TRI-MIX # 1 vials because FDA inspections found violations that may affect product 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 severity score of 4 (Severe) according to the rubric, as it involves potential adverse health consequences from sterility issues.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of TRI-MIX # 1, a prescription-only medication packaged in 5mL vials. The recall covers specific lots with expiration dates ranging from May 29, 2016, to June 30, 2016.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The agency has classified 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 affected products were distributed in Nevada. Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- 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 (8)
- Lot #: 02292016:67@10
- Exp. 05/29/2016
- Lot #: 03022016: 98@43
- Exp.05/31/2016
- Lot #: 03162016:25@32
- Exp. 06/14/2016
- Lot #: 03302016:36@36
- Exp.06/30/2016
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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