Jeffreys Drug Store Recalls Compounded Domperidone Capsules 10 mg
Jeffreys Drug Store is recalling compounded Domperidone capsules 10 mg because the product was marketed without an approved NDA/ANDA, meaning safety and efficacy have not been established.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the severity rubric, an FDA Class I recall mandates a score of 5 (Critical).
Plain-English summary
Jeffreys Drug Store, located in Canonsburg, Pennsylvania, is recalling compounded Domperidone capsules 10 mg. The affected products were dispensed in 60, 90, and 360-count bottles and correspond to 9- to 30-day prescriptions. The specific lot number is 071116-103323, with an expiration date of 1/7/2017.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Consequently, the safety and efficacy of the medication have not been established by the FDA. The agency has classified this recall as Class I.
Consumers who have purchased or been prescribed this specific lot of compounded Domperidone capsules should stop using the medication and contact their healthcare provider or pharmacist for further instructions. The product was distributed in Pennsylvania.
The recalled product
- Product
- Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
- Manufacturer
- Jeffreys Drug Store
- Category
- Drug — Compounded Prescription
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)
- Lot #: 071116-103323
- Exp. Date 1/7/2017
Distribution
Distributed in 1 state:
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