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

FDA recall notice · announced April 20, 2022 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Product distributed in California and Florida.
Lot/code information: Lot #: A1122P, G1421N, Exp. 1/1/2023
Quantity: 41 Tubes
Status: Terminated
Products in this recall event:
- 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 (D-0771-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.