Sun Pharmaceutical Recalls Carbidopa and Levodopa Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 8,537 bottles of Carbidopa and Levodopa tablets because they failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II is generally mapped to Severe (4) in this specific rubric structure where Class I is Critical (5) and Class II is Severe (4) due to the potential for adverse health consequences.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 8,537 bottles of Carbidopa and Levodopa Tablets USP 25 mg/250 mg. The affected products are distributed in 100-count and 500-count bottles and are available nationwide. The recall was initiated because the tablets failed to meet dissolution specifications.
The specific lot numbers and expiration dates for the recalled 100-count bottles are JKP5530A (Exp. 12/17), JKP3991A (Exp. 11/17), and JKR6535A (Exp. 07/18). The lot number and expiration date for the recalled 500-count bottles are JKP5529A (Exp. 11/17). The products are identified by NDC 62756-519-88 for 100-count bottles and NDC 62756-519-13 for 500-count bottles.
Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA)
- Brand
- CARBIDOPA AND LEVODOPA
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 8,537
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- a) JKP5530A Exp. 12/17
- JKP3991A Exp. 11/17
- JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17
UPCs (3)
- 0362756517882
- 0362756519886
- 0362756518889
Distribution
Distributed nationwide across the United States.
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