FDA Recall
Terminated
Historical recordClass II
GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014; PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904531360
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50 mg, NDC 00075770060, Pedigree: AD62992_11, EXP: 5/23/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003093, EXP: 6/13/2014; NIACIN TR, Capsule, 250 mg, NDC 00904062960, Pedigree: W003478, EXP: 6/20/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 009045
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD46265_10, EXP: 5/15/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca) may be potentially mislabeled as TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD21858_10, EXP: 5/1/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca) may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002767, EXP: 6/6/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD60240_20, EXP: 5/22/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: AD73521_25, EXP: 5/30/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; COENZYME Q-10, Capsule, 30 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W002819, EXP: 6/7/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass II
CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.
by Aidapak Services, LLC
- Reason
- Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.
- Published
- January 22, 2014
- Distribution
- Repacked drugs were distributed in Arizo…
View recall →
FDA Recall
Terminated
Historical recordClass I
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-557-09
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
by B. Braun Medical Inc
- Reason
- Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
- Published
- January 22, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Published
- January 15, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Published
- January 15, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
by Mutual Pharmaceutical Company, Inc.
- Reason
- Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
- Published
- January 15, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
by Watson Laboratories Inc
- Reason
- Presence of Foreign Substance; metal particulates were visually observed in the tablets.
- Published
- January 15, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
by Teva Pharmaceuticals USA
- Reason
- Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
- Published
- January 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
by Hospira Inc.
- Reason
- Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
- Published
- January 8, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
by Qualitest Pharmaceuticals
- Reason
- Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
- Published
- January 8, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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