Recalls / Class II
Class IID-0389-2019
Product
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
- Affected lot / code info
- Lot #: 43E021 and 43E023, Exp. 01/2020
Why it was recalled
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 118 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-01-15
- FDA classified
- 2019-01-22
- Posted by FDA
- 2019-01-30
- Terminated
- 2020-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0389-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.