Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
Reported: January 30, 2019 Initiated: January 15, 2019 #D-0389-2019
Product Description
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
Reason for Recall
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 118 bottles
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 118 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 30, 2019. Severity: Moderate. Recall number: D-0389-2019.
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