Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINorepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-288-18
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IINorepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-217-18
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-45
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-16
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIGlycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-118-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-258-45
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-15
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugCantrell Drug CompanyClass IIEphedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12
Lack of Sterility Assurance.
- 2017-08-16FDA-DrugAtHome Medical, Inc.Class IIOxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
- 2017-08-16FDA-DrugX-Gen Pharmaceuticals Inc.Class IINystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Presence of Foreign Substance: potential presence of plastic particles.
- 2017-08-16FDA-DrugTeva Pharmaceuticals USAClass IIIGlipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
- 2017-08-09FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIFamotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Failed Tablet/Capsule Specification: out of specification for tablet weight.
- 2017-08-09FDA-DrugTeva Pharmaceuticals USAClass IIFamotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Failed Tablet/Capsule Specification; out of specification for tablet weight
- 2017-08-09FDA-DrugTime-Cap Laboratories, Inc.Class IIIbuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
- 2017-08-09FDA-DrugVi-Jon, Inc.Class IIMagnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 30269; b) Premier Value Magnesium Citrate Oral Solution saline laxative very low sodium, UPC# 840986010255, NDC 68016-826-38, Distributed by: Chain Drug Consortium, Boca Raton, FL 33431; c) Swan Very Low Sodium Citroma Magne
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
- 2017-08-09FDA-DrugVistaPharm, Inc.Class IILactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
- 2017-08-09FDA-DrugVistaPharm, Inc.Class IILactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
- 2017-08-09FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IIAlka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- 2017-08-09FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IIAlka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- 2017-08-09FDA-DrugHospira a Pfizer CompanyClass IINeut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
Lack of Sterility Assurance
- 2017-08-09FDA-DrugHospira a Pfizer CompanyClass IISuccinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).
Lack of Sterility Assurance
- 2017-08-09FDA-DrugHospira a Pfizer CompanyClass II8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Lack of Sterility Assurance
- 2017-08-09FDA-DrugHospira a Pfizer CompanyClass IIPotassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Lack of Sterility Assurance
- 2017-08-09FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IIAlka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
- 2017-08-09FDA-DrugZydus Pharmaceuticals USA IncClass IIDivalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Failed Dissolution Specifications
- 2017-08-09FDA-DrugZydus Pharmaceuticals USA IncClass IIDivalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Failed Dissolution Specifications
- 2017-08-09FDA-DrugZydus Pharmaceuticals USA IncClass IIDivalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
Failed Dissolution Specifications
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