Wells Pharmacy Recalls MIC Combo Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling MIC Combo injectable vials because the agency could not ensure the product was sterile.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility, which poses a risk of harm (infection) but is not classified as Class I (likely to cause serious adverse health consequences) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Wells Pharmacy Network LLC is recalling 308 vials of MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes for product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates.
The recall was initiated due to a lack of assurance of sterility. The FDA 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.
Healthcare providers and patients should stop using the affected vials and contact Wells Pharmacy Network LLC for further instructions or a return. Specific lot codes identified in the recall include 03292016@5, 04122016@76, 04202016@5, 05182016@2, 06102016@2, 06282016@71, and 09092016@1.
The recalled product
- Product
- MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 308
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)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 03292016@5
- 04122016@76
- 04202016@5
- 05182016@2
- 06102016@2
- 06282016@71
- 09092016@1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC 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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