Why it was recalled
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
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
Lot numbers, UPCs & expiration codes
Lot #: 43E021 and 43E023, Exp. 01/2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0389-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2019
- FDA report date
- Jan 30, 2019
- Quantity
- 118 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0389-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81936
- Address
- 107 College Rd E
- Code information
- Lot #: 43E021 and 43E023, Exp. 01/2020
- Postal code
- 08540-6623
- Report date
- Jan 30, 2019
- Product type
- Drugs
- Recall number
- D-0389-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 118 bottles
- Termination date
- Mar 3, 2020
- Reason for recall
- Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 22, 2019