Wells Pharmacy Recalls NADH Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling NADH/Carnitine/Taurine/B12(M) Injectable kits because the agency could not ensure the product was sterile.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving injectable products where sterility is compromised are assigned a score of 4 (Severe) due to the potential for significant injury or infection, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 219 kits of NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit. The recall was initiated due to a lack of assurance of sterility for the compounded injectable product.
The affected product was prepared between February 22, 2016, and September 14, 2016, and is within its expiration date. Specific known kit lot codes include 04072016@29 and 08122016@103, while known vial lot codes include 03302016@13, 03252016@16, 08082016@58, and 08082016@67. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. 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.
The recalled product
- Product
- NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 219
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 (6)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 04072016@29
- 08122016@103. Known vial lot code: 03302016@13
- 03252016@16
- 08082016@58
- 08082016@67.
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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