Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Cortisol-Mc
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
88888-0043-31
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Abrams Royal Pharmacy II, LLC
- NDC code
- 88888-0043-31
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1231-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other wrong potency / content recalls from 2015
All wrong potency / content recalls
Class III · Low risk
NORepinephrine Bitartrate
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk
Lindane Lotion
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
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