FDA recall D-0011-2021

Product

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

Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI

Key facts

Status

Terminated

Initiation date

2020-09-16

Report date

2020-10-14

Termination date

2024-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Albuquerque, NM, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2021