Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Reported: April 3, 2019 Initiated: March 18, 2019 #D-1058-2019
Product Description
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Reason for Recall
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Details
- Recalling Firm
- Ingenus Pharmaceuticals Llc
- Units Affected
- 29,435 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.. Recalled by Ingenus Pharmaceuticals Llc. Units affected: 29,435 bottles.
Why was this product recalled? ▼
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2019. Severity: Low. Recall number: D-1058-2019.
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