MasterPharm Recalls Progesterone Tablets Due to Processing Control Deficiencies
MasterPharm LLC is recalling specific lots of Progesterone 150 mg tablets because they lack assurance of 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 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 specific lots of Progesterone (Rapid-Dissolve) 150 mg tablets. The recall was initiated due to a lack of processing controls, which means there is no assurance that the product conforms to required specifications.
The affected product is distributed nationwide in the United States. The specific lots involved are identified by the codes 02-13-2020:83@8 (Best Use Date 8/11/2020) and 02-14-2020:64@11 (Best Use Date 8/12/2020). Each bottle contains 30 tablets.
Consumers who have these specific lots of the medication should stop using them and contact their healthcare provider or pharmacist for guidance. The recalling firm, MasterPharm LLC, can be reached at (866) 630-5600 for further information.
The recalled product
- Product
- Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Manufacturer
- MasterPharm LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 288
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 (3)
- 02-13-2020:83@8
- BUD 8/11/2020 02-14-2020:64@11
- BUD 8/12/2020
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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