Parkinson's tablets recalled after bottles contained a higher strength tablet
Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a sealed bottle delivering a higher strength than labelled cannot be detected by the patient, and no injuries are reported.
Plain-English summary
Carbidopa, Levodopa and Entacapone Tablets, 25 mg/100 mg/200 mg, in 100-count bottles manufactured for Rising Pharma Holdings by Suven Pharmaceuticals in India, are being recalled for a product mix-up.
A complaint was received that a sealed medication bottle contained Carbidopa, Levodopa and Entacapone film-coated tablets at 37.5 mg/150 mg/200 mg instead of the labelled lower strength of 25 mg/100 mg/200 mg.
The recall covers 2,064 bottles from lot CS25070, expiring 31 March 2027. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Because the bottle is sealed and labelled for the lower strength, a patient would have no indication that the tablets inside deliver more carbidopa and levodopa than prescribed. Anyone holding the affected lot should contact their pharmacy or prescriber rather than continuing to take the tablets.
The recalled product
- Product
- CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
- Brand
- CARBIDOPA, LEVODOPA AND ENTACAPONE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Parkinson's treatment
- Hazard
- product-mixup
- wrong-strength
- overdose-risk
- mislabeling
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 (2)
- Lot # CS25070
- exp. date 03/31/2027
UPCs (5)
- 0316571690015
- 0316571694013
- 0316571692019
- 0316571691012
- 0316571693016
Distribution
Distributed nationwide across the United States.
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