Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, In
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine,
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine,
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugGrato Holdings, Inc.Class IIEnergique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
- 2016-01-27FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIIPhentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
- 2016-01-27FDA-DrugFreedom Pharmaceuticals IncClass IIBaclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.
Presence of Foreign Substance
- 2016-01-27FDA-DrugMutual Pharmaceutical Company, Inc.Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
- 2016-01-27FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIILindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
- 2016-01-27FDA-DrugAmerita Specialty Infusion ServicesClass IIIT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Lack of Assurance of Sterility
- 2016-01-27FDA-DrugAmerita Specialty Infusion ServicesClass IIBaclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Lack of Assurance of Sterility
- 2016-01-20FDA-DrugNational Vitamin Co IncClass IIILife-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
- 2016-01-20FDA-DrugFreedom Pharmaceuticals IncClass IIDomperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
- 2016-01-20FDA-DrugTeva Pharmaceuticals USAClass IIDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
- 2016-01-20FDA-DrugAmerisource Health ServicesClass IIHYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
Presence of Particulate Matter
- 2016-01-13FDA-DrugPQ CorporationClass IIIEPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
- 2016-01-13FDA-DrugAvantor Performance Materials IncClass IIIMagnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
- 2016-01-13FDA-DrugFreedom Pharmaceuticals IncClass III5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China
Subpotent Drug
- 2016-01-13FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIAzithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- 2016-01-13FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIAzithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
- 2016-01-06FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIClonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
cGMP Deviations
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIDextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IICefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IITobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IIRemicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass IINafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief