FDA Recall D-1124-2022
Calvin Scott & Company, Inc. · Albuquerque, NM
Class I — life-threatening Terminated 662 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1124-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- 1 physician in Alpharetta, GA
- Recall initiated
- 2021-01-15
- Classified by FDA Center
- 2022-06-09
- FDA published
- 2022-06-01
- Terminated
- 2022-11-08
- Recalling firm
- Calvin Scott & Company, Inc.
- Firm location
- Albuquerque, NM