Diclofenac Sodium Topical Solution 1.5% w/w recall: CGMP Deviations
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc.…
Why was Diclofenac Sodium Topical Solution 1.5% w/w recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc.…
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 528 bottles
- Distribution
- Nationwide within the USA.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)