The Recall Desk
ModerateFDA (Drugs)·D-0127-2017·Announced 2016-11-16

Wells Pharmacy Recalls Testosterone Cholesterol Pellets Due to Potency Issues

Wells Pharmacy Network is recalling Testosterone Cholesterol 100 mg pellets because they were found to be superpotent or subpotent.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. A score of 2 is assigned because potency deviations in compounded drugs represent a minor labeling or quality control error rather than a cosmetic defect, fitting the 'Minor labeling errors' or 'voluntary precautionary' criteria better than 'Low'.

Plain-English summary

Wells Pharmacy Network, LLC is recalling Testosterone Cholesterol 100 mg Pellets. The recall was initiated because the product was identified as superpotent or subpotent, meaning the drug concentration did not meet the required standards.

The affected product is identified by Lot Number 06072016@5 with a Beyond Use Date of 12/04/2016. The distribution pattern is listed as the U.S.

Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to proceed. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
Affected units
1

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)

  • Lot Number 06072016@5
  • BUD 12/04/2016

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →