Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-06-27FDA-DrugICU Medical IncClass II5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Lack of assurance of sterility: Bags have potential to leak.
- 2018-06-27FDA-DrugICU Medical IncClass II0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Lack of assurance of sterility: Bags have potential to leak.
- 2018-06-27FDA-DrugICU Medical IncClass II0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Lack of assurance of sterility: Bags have potential to leak.
- 2018-06-27FDA-DrugICU Medical IncClass II0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Lack of assurance of sterility: Bags have potential to leak.
- 2018-06-27FDA-DrugICU Medical IncClass II0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Lack of assurance of sterility: Bags have potential to leak.
- 2018-06-27FDA-DrugDr. Reddy's Laboratories, Inc.Class IIAtorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
- 2018-06-20FDA-DrugMylan Pharmaceuticals Inc.Class IIIMaxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
- 2018-06-20FDA-DrugAllergan, PLC.Class IAllergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290
Contraceptive Tablets Out of Sequence.
- 2018-06-20FDA-DrugBioDiagnostic InternationalClass IIMonsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IISilver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IIArgentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IIExpectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IIStomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IIIntestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IINausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugMBi Distributing Inc. dba MBi NutraceuticalsClass IITeething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
- 2018-06-20FDA-DrugInopak LtdClass IIOption Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIX-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugMedline Industries Inc (Northpoint Services)Class IIREADYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58.
Microbial Contamination of a Non-Sterile Product.
- 2018-06-20FDA-DrugPharMEDium Services, LLCClass IIHYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Superpotent and Subpotent
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IISDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGeritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRitussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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