Jubilant Cadista Pharmaceuticals, Inc. recalls Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmac…
- Recall date
- October 30, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0082-2018
- FDA classification
- Class III
- Brand / firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
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