Recalls / Class II
Class IID-0010-2021
Product
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
- Affected lot / code info
- Lot #: CS19192, CS19226, CS19263, Exp 10/20; CS19300, Exp 7/21; CS19338, Exp 8/21; CS20034, Exp 10/21; CS20077, Exp 1/22, CS20165, CS20241, Exp 4/22
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-0010-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.