Wells Pharmacy Recalls Injectable Compound Due to Sterility Assurance Concerns
Wells Pharmacy Network LLC is recalling 1,716 vials of a compounded injectable product nationwide due to a lack of 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 3/5 (High).
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 and involves a risk-of-harm product (injectable) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Wells Pharmacy Network LLC is recalling 1,716 vials of MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted due to a lack of assurance of sterility.
The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Specific known lot codes include 03302016@9, 04072016@15, 05022016@14, 05052016@5, 05162016@16, 06012016@11, 06092016@30, 06152016@15, 06212016@2, 07152016@8, and 08042016@21.
Consumers and healthcare providers should check their inventory for these specific lot codes and dates. If the product is found, it should be returned to the pharmacy or the recalling firm for disposal or credit.
The recalled product
- Product
- MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,716
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 (12)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 03302016@9
- 04072016@15
- 05022016@14
- 05052016@5
- 05162016@16
- 06012016@11
- 06092016@30
- 06152016@15
- 06212016@2
- 07152016@8
- 08042016@21.
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.
See all 97 products in this recall →Related recalls
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