Wells Pharmacy Recalls DMSO and Lidocaine Solution Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 438 vials of DMSO with Lidocaine solution because the product lacks assurance of 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 hazard involves a lack of assurance of sterility in a compounded pharmaceutical product, which carries a risk of serious injury or death from infection.
Plain-English summary
Wells Pharmacy Network LLC is recalling 438 vials of DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04132016@69, 04272016@9, 05142016@13, 06162016@129, 07052016@12, and 07292016@2.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Pharmaceutical
- Affected units
- 438
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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 04132016@69
- 04272016@9
- 05142016@13
- 06162016@129
- 07052016@12
- 07292016@2.
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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