Recalls / Class II
Class IID-0455-2017
Product
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.
- Brand name
- Carbidopa And Levodopa
- Generic name
- Carbidopa And Levodopa
- Active ingredients
- Carbidopa, Levodopa
- Route
- Oral
- NDCs
- 62756-517, 62756-518, 62756-519, 62756-985
- FDA application
- ANDA078536
- Affected lot / code info
- a) JKP5530A Exp. 12/17, JKP3991A Exp. 11/17, JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 8,537 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-12
- FDA classified
- 2017-02-02
- Posted by FDA
- 2017-02-08
- Terminated
- 2018-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0455-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.