Why it was recalled
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Product description
Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
Lot numbers, UPCs & expiration codes
Lot #:19207; Exp. Date: 9/21; 19251, Exp. Date: 9/20; 19284, Exp. Date:10/20; 19316, Exp. Date: 12/20
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-1530-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2020
- FDA report date
- Aug 26, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Calvin Scott & Company, Inc.
Original FDA data
Every field from FDA enforcement report D-1530-2020, exactly as published.
Show all FDA fields
- City
- Albuquerque
- State
- NM
- Status
- Terminated
- Country
- United States
- Event ID
- 86123
- Address
- 209 Eubank Blvd Ne
- Code information
- Lot #:19207; Exp. Date: 9/21; 19251, Exp. Date: 9/20; 19284, Exp. Date:10/20; 19316, Exp. Date: 12/20
- Postal code
- 87123-2745
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1530-2020
- Classification
- Class II
- Recalling firm
- Calvin Scott & Company, Inc.
- Termination date
- Apr 11, 2024
- Reason for recall
- CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 27, 2020
- Initial firm notification
- Center classification date
- Aug 20, 2020