Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…
Reason Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Reason Product Mix-Up: A foreign tablet was found in bottle.
Reason Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug…
Reason Failed Dissolution Specifications
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