Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp. 12/31/2023; 16342, 16343, Exp. 1/31/2024; 16503, 16504, Exp. 3/31/2024; 16632, Exp. 4/30/2024; 16715, 16731, Exp. 5/31/2024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teligent Pharma, Inc.
- Reason for Recall:
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
Product Codes/Lot Numbers:
Batch: 15384, Exp. 3/31/2023; 15646, Exp. 5/31/2023; 15971, Exp. 9/30/2023; 16206, 16226, Exp. 11/30/2023; 16268, Exp. 12/31/2023; 16342, 16343, Exp. 1/31/2024; 16503, 16504, Exp. 3/31/2024; 16632, Exp. 4/30/2024; 16715, 16731, Exp. 5/31/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0680-2022
Related Recalls
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
Teligent Pharma
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.