Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-08-09FDA-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
- 2017-08-09FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITestosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
CGMP Deviations
- 2017-08-09FDA-DrugTeva Pharmaceuticals USAClass IIIAlbuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
- 2017-08-09FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIPravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
- 2017-08-09FDA-DrugPrecision Dose Inc.Class IICarbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
- 2017-08-09FDA-DrugApace KY LLCClass IICyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
- 2017-08-09FDA-DrugApace KY LLCClass IIAmantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPotassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPotassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Lack of Assurance of Sterility; product has the potential to leak.
- 2017-08-02FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
Lack of Assurance of Sterility; product has the potential to leak.
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