Recalls / Class II
Class IID-0009-2021
Product
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
- Affected lot / code info
- Lot #: CS19311, CS19337, Exp 12/20; CS20018B, CS20019, CS20037, CS20075, CS20076, CS20112, CS20169, Exp 8/21; CS20168, Exp 12/21; CS20199, Exp 5/22; CS20243, Exp 7/22
Why it was recalled
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Recalling firm
- Firm
- Calvin Scott & Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 209 Eubank Blvd Ne, N/A, Albuquerque, New Mexico 87123-2745
Distribution
- Quantity
- N/A
- Distribution pattern
- Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI
Timeline
- Recall initiated
- 2020-09-16
- FDA classified
- 2020-10-02
- Posted by FDA
- 2020-10-14
- Terminated
- 2024-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.