Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Drug: Lansoprazole
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
CGMP Deviations
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
FAILED DISSOLUTION SPECIFICATIONS
FAILED DISSOLUTION SPECIFICATIONS
Failed Dissolution Specifications
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
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