The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0373-2017·Announced 2017-01-11

Wells Pharmacy Recalls MIC/B-COMP+LIDO Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable vials 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 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectables) are rated as Severe (4).

Plain-English summary

Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vials. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was compounded by Wells Pharmacy in Ocala, FL. The recall includes 4 vials per unit. The distribution pattern is nationwide. The recall covers all lot codes of the product prepared between 02/22/2016 and 09/14/2016, within expiry. A known lot code is 07132016@5.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Injectable
Hazard
Affected units
4

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: 07132016@5.

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 →

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