Drug 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
D-0771-2022
Product summary
- Event
- Event 89943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 Tubes
- Official record key
drug-enforcement:D-0771-2022
Official wording
Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Code information: Lot #: A1122P, G1421N, Exp. 1/1/2023
Distribution pattern: Product distributed in California and Florida.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations