Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharma…
SUN PHARMACEUTICAL INDUSTRIES INC · Failed Stability Specifications
- Status
- Ongoing
- City
- Princeton
- State
- NJ
- Country
- United States
- Classification
- Not Yet Classified
- Product type
- Drugs
- Event ID
- 99876
- 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
- N/A
- Distribution pattern
- U.S. Nationwide.
- Recall number
- N/A
- Product quantity
- N/A
- Reason for recall
- Failed Stability Specifications
- Recall initiation date
- 20260914
- Report date
- 20260923
- Code info
- LOT AD49605, LOT AD49606; Exp. 05/31/2027
- Product description
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1
- Harmonized identifiers (openFDA)
- Application number
- ANDA064022
- Brand name
- NYSTATIN
- Generic name
- NYSTATIN
- Manufacturer name
- Sun Pharmaceutical Industries, Inc.
- Product NDC
- 51672-1289
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Substance name
- NYSTATIN
- RxCUI
- 543546
- SPL ID
- 3908cf94-b2b6-30a4-e063-6394a90add43
- SPL set ID
- 4d845b3f-ca26-4c47-b424-b6d783cc10e5
- Package NDC
- 51672-1289-1, 51672-1289-2
- Is original packager
- true
- Nui
- N0000175498, M0017172
- Pharm class epc
- Polyene Antifungal [EPC]
- Pharm class cs
- Polyenes [CS]
- UNII
- BDF1O1C72E