Why it was recalled
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Product description
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
Lot numbers, UPCs & expiration codes
Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
Where it was sold
Nationwide within the United States
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-0279-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 6, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 9,193 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0279-2019, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81523
- Address
- 6111 Broken Sound Pkwy NW Ste 170
- Code information
- Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
- Postal code
- 33487-2875
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0279-2019
- Classification
- Class III
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Product quantity
- 9,193 bottles
- Termination date
- Nov 26, 2019
- Reason for recall
- Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 6, 2018
- Initial firm notification
- Center classification date
- Nov 20, 2018