Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Reported: October 5, 2022 Initiated: September 16, 2022 #D-1543-2022
Product Description
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Reason for Recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Details
- Recalling Firm
- Novartis Pharmaceuticals Corporation
- Units Affected
- 132,999 cartons
- Distribution
- Nationwide and Puerto Rico
- Location
- East Hanover, NJ
Frequently Asked Questions
What product was recalled? ▼
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.. Recalled by Novartis Pharmaceuticals Corporation. Units affected: 132,999 cartons.
Why was this product recalled? ▼
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Moderate. Recall number: D-1543-2022.
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