MECLIZINE HYDROCHLORIDE
Generic: MECLIZINE HYDROCHLORIDE
Chartwell RXManufacturer
ORALRoute
MECLIZINE HYDROCHLORIDEActive Substance
2022-08-11Original Approval
MECLIZINE HYDROCHLORIDE is FDA application ANDA203003, sponsored by CHARTWELL RX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class I2022-03-08
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, ManufacturedLabeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochlo
Class II2026-03-16
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NFailed tablet specifications.
Class III2017-10-30
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista PharmaceMarketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class II2022-04-13
Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per cartoncGMP deviations: Temperature abuse
Top Reported Reactions
1
DIZZINESS
1,633 reports
2
NAUSEA
1,420 reports
3
FATIGUE
1,369 reports
4
HEADACHE
1,060 reports
5
DIARRHOEA
1,046 reports
6
PAIN
1,006 reports
7
FALL
998 reports
8
DYSPNOEA
878 reports
9
CHRONIC KIDNEY DISEASE
841 reports
10
ASTHENIA
818 reports