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Class II: temporary or reversible health riskTerminated

Ingenus Pharmaceuticals Clobetasol Propionate Foam Recall

Clobetasol Propionate Foam, 0

Ingenus Pharmaceuticals Llc · Orlando, FL

Risk level
Class II
Reported by FDA
Jan 26, 2022
Recall ID
D-0374-2022
Check your lot numberHow we source this data

Summary

Ingenus Pharmaceuticals recalled Clobetasol Propionate Foam starting Jan 10, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0374-2022 on Jan 26, 2022. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

Lot numbers, UPCs & expiration codes

a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.

Where it was sold

Nationwide in the USA

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-0374-2022
Classification
Class II
Status
Terminated
Recall initiated
Jan 10, 2022
FDA report date
Jan 26, 2022
Quantity
45,173 cans
Recall type
Voluntary: Firm initiated
Recalling firm
Ingenus Pharmaceuticals Llc

Original FDA data

Every field from FDA enforcement report D-0374-2022, exactly as published.

Show all FDA fields
City
Orlando
State
FL
Status
Terminated
Country
United States
Event ID
89393
Address
4190 Millenia Blvd
Code information
a) Lots: 32921 Exp. 06/2022; 33152 Exp. 08/2022; 33340 Exp. 11/2022; b) Lots: 33152 Exp. 08/2022; 33340 Exp. 11/2022.
Postal code
32839-6408
Report date
Jan 26, 2022
Product type
Drugs
Recall number
D-0374-2022
Classification
Class II
Recalling firm
Ingenus Pharmaceuticals Llc
Product quantity
45,173 cans
Termination date
Aug 15, 2023
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jan 10, 2022
Initial firm notification
Letter
Center classification date
Jan 14, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0374-2022, published Jan 26, 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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