Wells Pharmacy Recalls TitanMax Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in an injectable drug which poses a high risk of serious harm, align with a Severe rating (Score 4).
Plain-English summary
Wells Pharmacy Network LLC is recalling 18 vials of TitanMax-MIC/12/CA/CH/L/D Injectable, a compounded medication prepared in Ocala, Florida. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product consists of 30 mL vials containing a specific combination of active ingredients. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. One known lot code is 07212016@15. The product was distributed nationwide.
Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the medication. Do not use the product until further notice.
The recalled product
- Product
- TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 18
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)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 07212016@15.
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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