Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Product Mix-Up: A foreign tablet was found in bottle.
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
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 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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