Multi-event January 2021 FDA Recall Drug by Calvin Scott & Company, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Calvin Scott & Company, Inc. on January 15, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in 1 physician in Alpharetta, GA and the recall is currently terminated.

Reported Recall Events

D-1123-2022 TERMINATED D-1124-2022 TERMINATED

Recall Number: D-1123-2022

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.
Initiated
01-15-2021
Reported
06-01-2022
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90183
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Calvin Scott & Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
1 physician in Alpharetta, GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50

Batch or Lot Expiration Information

Lot# CSI Lot: CS-20274-005, Exp 5/22

Recall Number: D-1124-2022

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.
Initiated
01-15-2021
Reported
06-01-2022
Quantity
10 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90183
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Calvin Scott & Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
1 physician in Alpharetta, GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2022
Product Description About Product Description
Full technical description of the product.
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05

Batch or Lot Expiration Information

Lot# CSI Lot: CS-20180W-004, Exp 3/22