D-0011-2021 Class II Terminated
FDA drug recall D-0011-2021 was initiated by Calvin Scott & Company, Inc. on September 16, 2020 and is designated Class II. Reason for recall: cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. The recall status is terminated (terminated April 22, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- October 14, 2020
- Initiation Date
- September 16, 2020
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Reason for Recall
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Distribution Pattern
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
Code Information
Lot #: CS19309, CS20098, Exp 12/21