Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Reported: June 17, 2015 Initiated: April 17, 2015 #D-1116-2015
Product Description
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Reason for Recall
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 93,237 Bottles
- Distribution
- United States Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 93,237 Bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2015. Severity: Moderate. Recall number: D-1116-2015.
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