MasterPharm Recalls Estriol 8 mg Capsules Due to Processing Control Deficiencies
MasterPharm LLC is recalling Estriol 8 mg capsules 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 due to a lack of processing controls, which fits the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injuries.
Plain-English summary
MasterPharm LLC is voluntarily recalling Estriol 8 mg Capsules, 90 capsules per bottle, distributed nationwide in the U.S. 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 is identified by the code 01-28-2020:71@3 and has a best-use date of 7/26/2020. The quantity involved is 300 capsules. 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, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for further instructions or a refund.
The recalled product
- Product
- Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Manufacturer
- MasterPharm LLC
- Category
- Drug — Pharmaceutical
- Hazard
- 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 (2)
- 01-28-2020:71@3
- 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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