Why it was recalled
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 04012015@45, Expiry: 09/28/2015
Where it was sold
United States including: Texas
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1231-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 30 count: 5 Bottles; 90 count: 2 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abrams Royal Pharmacy II, LLC
Original FDA data
Every field from FDA enforcement report D-1231-2015, exactly as published.
Show all FDA fields
- City
- Plano
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 71598
- Address
- 4909 W Park Blvd Ste 177
- Code information
- Lot #: 04012015@45, Expiry: 09/28/2015
- Postal code
- 75093-2311
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1231-2015
- Classification
- Class III
- Recalling firm
- Abrams Royal Pharmacy II, LLC
- Product quantity
- 30 count: 5 Bottles; 90 count: 2 Bottles
- Termination date
- Jan 13, 2017
- Reason for recall
- Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- United States including: Texas
- Recall initiation date
- Jun 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2015