FDA recall D-1124-2022

Product

Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05

Reason for recall

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Distribution

1 physician in Alpharetta, GA

Key facts

Status

Terminated

Initiation date

2021-01-15

Report date

2022-06-01

Termination date

2022-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Albuquerque, NM, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2022