D-0773-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 27, 2022
- Initiation Date
- March 24, 2022
- Termination Date
- October 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 528 bottles
Product Description
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
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.
Distribution Pattern
Nationwide within the USA.
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