Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,…
SUN PHARMACEUTICAL INDUSTRIES INC · CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Status
- Completed
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 93820
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address 1
- 2 Independence Way
- Address 2
- N/A
- Postal code
- 08540-6620
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
- Recall number
- D-0270-2024
- Product quantity
- 15,768 bottles
- Reason for recall
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Recall initiation date
- 20240118
- Center classification date
- 20240125
- Report date
- 20240131
- Code info
- Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025.
- Product description
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
- Harmonized identifiers (openFDA)
- Application number
- ANDA200484
- Brand name
- NIACIN
- Generic name
- NIACIN
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 47335-539, 47335-614, 47335-613
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- NIACIN
- RxCUI
- 1098134, 1098141, 1098143
- SPL ID
- bc18daa3-5321-43bd-9d00-dabd9adac571
- SPL set ID
- 8e290f96-e8c6-47fd-863f-1c9480f28d9b
- Package NDC
- 47335-539-83, 47335-539-81, 47335-539-88, 47335-539-08, 47335-539-18, 47335-614-83, 47335-614-81, 47335-614-88, 47335-614-18, 47335-613-83, 47335-613-81, 47335-613-88, 47335-613-08, 47335-613-18
- Is original packager
- true
- Upc
- 0347335613810, 0347335614817, 0347335539813
- Nui
- N0000175594, M0014839
- Pharm class epc
- Nicotinic Acid [EPC]
- Pharm class cs
- Nicotinic Acids [CS]
- UNII
- 2679MF687A