Class II · Moderate risk Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC…
Reason Failed tablet specifications.
Is Meclizine recalled?
16 FDA recalls mention Meclizine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Meclizine.
Class II · Moderate risk Terminated
Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx…
Reason cGMP deviations: Temperature abuse
Class I · High risk Terminated
Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by…
Reason Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled…
Class II · Moderate risk Ongoing
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ…
Reason Labeling: Incorrect Instructions
Class II · Moderate risk Terminated
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S…
Reason Subpotent Drug
Class III · Low risk Terminated
WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b)…
Reason Subpotent Drug
Class III · Low risk Terminated
Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western…
Reason Subpotent Drug
Class III · Low risk Terminated
Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave…
Reason Subpotent Drug
Class III · Low risk Terminated
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals…
Reason Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class III · Low risk Terminated
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk Terminated
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles…
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.
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