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
Reported: February 14, 2024 Initiated: February 1, 2024 #D-0318-2024
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- NATCO Pharma Limited
- Units Affected
- 4260 bottles
- Distribution
- Nationwide in the USA
- Location
- Rangareddy
Frequently Asked Questions
What product 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. Recalled by NATCO Pharma Limited. Units affected: 4260 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2024. Severity: Moderate. Recall number: D-0318-2024.
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