Allegiant Health Recalls

FDA
3
Total Recalls
1
Agencies
Jun 2015
First Recall
Mar 2017
Latest Recall
Sort: Newest first Highest severity

Showing 1-3 of 3 recalls

FDA

HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729

cGMP deviations - presence of rubber particles found loose in the bulk product.
FDA

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
FDA

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hau

CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.