The Recall Desk
SevereFDA (Drugs)·D-0370-2017·Announced 2017-01-11

Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN Injectable due to a lack of assurance of sterility.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly when the agency's own classification is cited.

Plain-English summary

Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 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 covers 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 04082016@4, 05102016@1, 05172016@6, 06032016@3, 06092016@17, 06212016@42, 07012016@32, 07272016@16, 08172016@13, and 4252016@21.

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
MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Affected units
933

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 (11)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 04082016@4
  • 05102016@1
  • 05172016@6
  • 06032016@3
  • 06092016@17
  • 06212016@42
  • 07012016@32
  • 07272016@16
  • 08172016@13
  • 4252016@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 →