MasterPharm Recalls Progesterone Troches Due to Processing Control Deficiencies
MasterPharm LLC is recalling specific lots of Progesterone 200 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.
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 2/5 (Moderate).
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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a theoretical lack of assurance of conformity rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
MasterPharm LLC is voluntarily recalling specific lots of Progesterone 200 mg Troches, 30 troches per bottle. The recall is being conducted because of a lack of processing controls, which means there is a lack of assurance that the product conforms to its specifications.
The affected product was distributed nationwide in the United States. The specific lot codes involved in this recall are 02-06-2020:24@4, 02-06-2020:60@3, and 02-06-2020:65@2, all with a best-use date of August 4, 2020.
Consumers who have these specific lots of the product should stop using them and contact MasterPharm LLC at (866) 630-5600 for further instructions or a refund.
The recalled product
- Product
- Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Manufacturer
- MasterPharm LLC
- Category
- Drug — Pharmaceutical
- Affected units
- 300
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 (4)
- 02-06-2020:24@4
- 02-06-2020:60@3
- 02-06-2020:65@2
- BUD 8/4/2020
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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