Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123,
Summary
The FDA issued a Class I for Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calv by Calvin Scott & Company, Inc.. Reason: Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 m.
Details
Source
Drug Recall
External ID
D-1124-2022
Action Date
2022-06-01
Status
Terminated
Category
drug
Product Description
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Lot/Code Info: CSI Lot: CS-20180W-004, Exp 3/22
Quantity Affected: 10 bottles
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-01-15
Company
Albuquerque, NM
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 101 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Calvin Scott & Company, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Calvin Scott & Company, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Calvin Scott & Company, Inc. have FDA actions?
Calvin Scott & Company, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1124-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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