Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIGUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904513559
Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP: 5/28/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIPSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904512559
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W002855, EXP: 6/7/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium) may be potentially mislabeled as tiZANidine HCL, Tablet, 2 mg, NDC 57664050289, Pedigree: W003750, EXP: 6/26/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium may be potentially mislabeled as TRIAMTERENE/HCTZ, Tablet, 37.5 mg/25 mg, NDC 00378135201, Pedigree: AD28333_4, EXP: 5/6/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIPSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC, NDC 00904505360
Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC 49348041010, Pedigree: AD52993_28, EXP: 5/20/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICOENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546
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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IINIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713
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
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIOMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N
- 2014-01-22FDA-DrugAidapak Services, LLCClass IICALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.
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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160.
Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.
- 2014-01-22FDA-DrugMariposa Labs, LLCClass IINorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201
Microbial Contamination of Non-Sterile Products: Arthritis Relief Cream failed microbiological specifications.
- 2014-01-22FDA-DrugHospira Inc.Class IAminosyn 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.
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IISODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IIDT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass II0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IICalcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IIWB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IIVIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IIVANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IITRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IITROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IITRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IITESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IITESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
- 2014-01-22FDA-DrugSpecialty Medicine Compounding PharmacyClass IIQUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
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