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Class I: serious health riskTerminated

Calvin Scott & Benzonatate capsules Recall

Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scot…

Calvin Scott & Company, Inc. · Albuquerque, NM

Risk level
Class I
Reported by FDA
Jun 1, 2022
Recall ID
D-1124-2022
Check your lot numberHow we source this data

Summary

Calvin Scott & recalled Benzonatate capsules starting Jan 15, 2021. The FDA classified it as Class I (serious health risk) and published enforcement report D-1124-2022 on Jun 1, 2022. Reason: 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. Status: Terminated.

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.

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

1 physician in Alpharetta, GA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1124-2022
Classification
Class I
Status
Terminated
Recall initiated
Jan 15, 2021
FDA report date
Jun 1, 2022
Quantity
10 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Calvin Scott & Company, Inc.

Original FDA data

Every field from FDA enforcement report D-1124-2022, exactly as published.

Show all FDA fields
City
Albuquerque
State
NM
Status
Terminated
Country
United States
Event ID
90183
Address
209 Eubank Blvd Ne
Code information
CSI Lot: CS-20180W-004, Exp 3/22
Postal code
87123-2745
Report date
Jun 1, 2022
Product type
Drugs
Recall number
D-1124-2022
Classification
Class I
Recalling firm
Calvin Scott & Company, Inc.
Product quantity
10 bottles
Termination date
Nov 8, 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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Distribution pattern
1 physician in Alpharetta, GA
Recall initiation date
Jan 15, 2021
Initial firm notification
Telephone
Center classification date
Jun 9, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1124-2022, published Jun 1, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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