MasterPharm Recalls Formula 82F Minoxidil Tretinoin Fluocinolone Acetonide Finasteride
MasterPharm LLC is recalling 462 units of Formula 82F topical solution due to a lack of processing controls that compromised product specifications.
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 II and involves a lack of processing controls without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
MasterPharm LLC is voluntarily recalling 462 units of Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottles. The recall was initiated because of a lack of processing controls, which means there was a lack of assurance that the product conformed to its specifications.
The affected product was distributed nationwide in the U.S. The specific lots involved include those with manufacturing dates of 01-15-2020, 01-09-2020, 01-20-2020, 01-23-2020, 01-29-2020, and 02-03-2020, with corresponding best-use dates ranging from July 2020 to late July 2020.
Consumers who have this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
- Manufacturer
- MasterPharm LLC
- Category
- Drug — Topical Prescription
- Affected units
- 462
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 (7)
- 01-15-2020:70@3
- 01-09-2020:48@2
- BUD 7/7/2020 01-20-2020:79@11
- 01-23-2020:55@11
- BUD 7/18/2020 01-29-2020:18@1
- 02-03-2020:89@8
- BUD 7/26/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by MasterPharm 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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