Recalls / Class I
Class ID-1124-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
- Affected lot / code info
- CSI Lot: CS-20180W-004, Exp 3/22
Why it was recalled
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.
Recalling firm
- Firm
- Calvin Scott & Company, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 209 Eubank Blvd Ne, Albuquerque, New Mexico 87123-2745
Distribution
- Quantity
- 10 bottles
- Distribution pattern
- 1 physician in Alpharetta, GA
Timeline
- Recall initiated
- 2021-01-15
- FDA classified
- 2022-06-09
- Posted by FDA
- 2022-06-01
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1124-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.