Class II · Moderate risk Ongoing
Diovan
Reason Failed Dissolution Specifications
Lansoprazole Delayed-Release Capsules USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Recalling firm
- NATCO Pharma Limited
- NDC code
- 16571-742-41
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0318-2024
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.
Other East recalls
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Class II · Moderate risk Ongoing
Clindamycin Palmitate Hydrochloride for Oral Solution
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
Rising
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class I · High risk Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
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