Progesterone E4M SR 100 mg capsules recalled for expired components
MPRX, Inc. is recalling specific lots of compounded Progesterone E4M SR 100 mg capsules because they were made with expired components and have incorrect labeling.
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. The hazard involves labeling errors and the use of expired components, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
MPRX, Inc. dba Medical Park Pharmacy is recalling three bottles of Progesterone E4M SR 100 mg capsules. The recall is limited to Lot 61219:42 with a use-by date of 03/24/2020. These products were distributed in Texas.
The recall was initiated due to labeling issues, specifically incorrect or missing lot and expiration dates. Additionally, the source text states that the products were compounded using expired components.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Progesterone E4M SR 100 mg capsules
- Manufacturer
- MPRX, Inc. dba Medical Park Pharmacy
- Category
- Drug — Compounded Prescription
- Affected units
- 3
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 (1)
- Lot: 61219:42 Use by: 03/24/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 18 recalled by MPRX, Inc. dba Medical Park Pharmacy 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 18 products in this recall →Related recalls
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