Abrams Royal Pharmacy Recalls CORTISOL-MC Capsules for Uniformity Failures
Abrams Royal Pharmacy II is recalling CORTISOL-MC 10mg capsules because they failed uniformity of dosage unit specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences or death.
Plain-English summary
Abrams Royal Pharmacy II, LLC is recalling CORTISOL-MC, 10mg capsules, packaged in 30 and 90 count bottles. The product is identified by NDC 88888-0043-31 and Lot # 04012015@45, with an expiration date of 09/28/2015.
The recall was initiated because the product failed Content Uniformity Specifications, specifically the Uniformity of Dosage Units specifications. This means the amount of active ingredient in individual capsules may not be consistent with the labeled strength.
The affected product was distributed in the United States, including Texas. Consumers who have this specific lot of CORTISOL-MC should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31
- Manufacturer
- Abrams Royal Pharmacy II, LLC
- Category
- Drug — Prescription Medication
- Hazard
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 #: 04012015@45
- Expiry: 09/28/2015
Distribution
Distributed in 1 state:
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