Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3…
Reason CGMP Deviations
Is East recalled?
1,061 FDA recalls mention East. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of East.
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or…
Reason CGMP Deviations
Class I · High risk Terminated
Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By…
Reason Microbial contamination of non-sterile products.
Class II · Moderate risk Terminated
Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3…
Reason Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk Ongoing
AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC…
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL…
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo…
Reason Failed impurities/degradation specifications
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC…
Reason Superpotent and Failed Tablet/Capsule Specifications
Class III · Low risk Terminated
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY…
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class III · Low risk Terminated
Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road…
Reason Discoloration
Class II · Moderate risk Terminated
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279…
Reason Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
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
Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For…
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech…
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas…
Reason Marketed Without an Approved NDA/ANDA
Class III · Low risk Terminated
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
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