PlainRecalls
FDA Drug Moderate Class II Terminated

Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1037-2022

Product Description

Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
1 box/50 blister packs per box
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 box/50 blister packs per box.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1037-2022.