Jubilant Cadista Pharmaceuticals, Inc. recalls MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury,…
- Recall date
- August 27, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1205-2018
- FDA classification
- Class III
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
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