Drug product
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
D-0773-2022
Product summary
- Event
- Event 89945
- Status
- Terminated
- Classification
- Class II
- Quantity
- 528 bottles
- Official record key
drug-enforcement:D-0773-2022
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: Lots: E1220B, Exp.: 01/31/2023; F0220M, Exp.: 3/31/2023; F2320A, Exp.: 3/31/2023; F3020M, Exp.: 3/31/2023; G0920Q, Exp.: 3/31/2023; C0821M, Exp.: 1/31/2024; J1920, Exp.: 5/31/2023; E2421j, Exp.: 4/30/2024
Distribution pattern: Nationwide within the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations