Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834…
Reason Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations;
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 32503 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; c) Equate NDC 49035-592-38 UPC 6 81131 28715 9 Distributed By: Walmart, Inc. Bentonville, AR 72716; d) HEB UPC 0 41220 51088 7 Made With Pride & Care For H-E-B San Antonio, TX 78204; Kroger UPC 0 41260 00871 9 Distributed By The Kroger Co. Cincinnati, Ohio 45202; e) Leader NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; f) Rexall UPC 0 72785 13417 1 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13417 1 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; g) Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (purple label), Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 (blue label)
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
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