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Class II: temporary or reversible health riskTerminated

Preferred Pharmaceuticals Econazole Nitrate Cream Recall

Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pha…

Preferred Pharmaceuticals, Inc. · Anaheim, CA

Risk level
Class II
Reported by FDA
Apr 20, 2022
Recall ID
D-0771-2022
Check your lot numberHow we source this data

Summary

Preferred Pharmaceuticals recalled Econazole Nitrate Cream starting Mar 24, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0771-2022 on Apr 20, 2022. Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. Status: Terminated.

Why it was recalled

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Product description

Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03

Lot numbers, UPCs & expiration codes

Lot #: A1122P, G1421N, Exp. 1/1/2023

Where it was sold

Product distributed in California and Florida.

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-0771-2022
Classification
Class II
Status
Terminated
Recall initiated
Mar 24, 2022
FDA report date
Apr 20, 2022
Quantity
41 Tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Preferred Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0771-2022, exactly as published.

Show all FDA fields
City
Anaheim
State
CA
Status
Terminated
Country
United States
Event ID
89943
Address
1250 N Lakeview Ave Ste O
Code information
Lot #: A1122P, G1421N, Exp. 1/1/2023
Postal code
92807-1801
Report date
Apr 20, 2022
Product type
Drugs
Recall number
D-0771-2022
Classification
Class II
Recalling firm
Preferred Pharmaceuticals, Inc.
Product quantity
41 Tubes
Termination date
Nov 17, 2023
Reason for recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
Distribution pattern
Product distributed in California and Florida.
Recall initiation date
Mar 24, 2022
Initial firm notification
E-Mail
Center classification date
Apr 14, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0771-2022, published Apr 20, 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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