Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
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 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
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
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