Class I · High risk Terminated
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview…
Reason Non-Sterility
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 I · High risk Terminated
BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview…
Reason Non-Sterility
Class I · High risk Terminated
BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview…
Reason Non-Sterility
Class III · Low risk Terminated
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East…
Reason Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk Terminated
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by…
Reason Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk Terminated
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279…
Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind…
Reason Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Terminated
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A…
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East…
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class I · High risk Terminated
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East…
Reason Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Class II · Moderate risk Terminated
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279…
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk Terminated
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b)…
Reason Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class III · Low risk Terminated
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun…
Reason Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Class II · Moderate risk Terminated
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc…
Reason Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind…
Reason Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very…
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by…
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk Terminated
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and…
Reason cGMP violations
Class II · Moderate risk Ongoing
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279…
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
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