Why it was recalled
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Product description
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
Lot numbers, UPCs & expiration codes
a) Lot #: 19236, Exp. Date 10/20 b) Lot #: 19170; 19236, Exp. Date: 09/20; 19303, Exp. Date: 11/20; 19347, Exp. Date: 12/20; 19353, Exp. Date: 01/21: 20032, 20047, Exp. Date: 2/21. c) Lot #: 19236, Exp. Date 10/20
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-1522-2020
- 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-1522-2020, 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
- a) Lot #: 19236, Exp. Date 10/20 b) Lot #: 19170; 19236, Exp. Date: 09/20; 19303, Exp. Date: 11/20; 19347, Exp. Date: 12/20; 19353, Exp. Date: 01/21: 20032, 20047, Exp. Date: 2/21. c) Lot #: 19236, Exp. Date 10/20
- Postal code
- 87123-2745
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1522-2020
- 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
- Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 27, 2020
- Initial firm notification
- Center classification date
- Aug 20, 2020