Why it was recalled
Failed Dissolution Specifications
Product description
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India.
Lot numbers, UPCs & expiration codes
a) JKP5530A Exp. 12/17, JKP3991A Exp. 11/17, JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17
Where it was sold
Nationwide
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-0455-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2017
- FDA report date
- Feb 8, 2017
- Quantity
- 8,537 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0455-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76230
- Address
- 270 Prospect Plains Rd
- Code information
- a) JKP5530A Exp. 12/17, JKP3991A Exp. 11/17, JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17
- Postal code
- 08512-3605
- Report date
- Feb 8, 2017
- Product type
- Drugs
- Recall number
- D-0455-2017
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 8,537 bottles
- Termination date
- Jun 29, 2018
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 2, 2017