Reported Nov 22, 2017 · Terminated
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista…
Jubilant Cadista Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249
Is this the product you have?
- Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only
- Manufactured byJubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
- Lot codes and dates
Lot # 17P0430Exp 05/19
- Amount recalled
- 744 bottles
Where it was sold
- Nationwide
Why it was recalled
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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