PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 20, 2022 Initiated: March 24, 2022 #D-0771-2022

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

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.

Details

Units Affected
41 Tubes
Distribution
Product distributed in California and Florida.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 41 Tubes.
Why was this product recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 20, 2022. Severity: Moderate. Recall number: D-0771-2022.