June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 5511
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Failed Impurities/Degradation Specifications
June 27, 2018DrugsFDA
ICU Medical Inc recalls 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -
Hazard: Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
June 20, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmac
Hazard: Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
June 20, 2018DrugsFDA
Allergan, PLC. recalls Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: A
Hazard: Contraceptive Tablets Out of Sequence.
June 20, 2018DrugsFDA
BioDiagnostic International recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Ma
Hazard: CGMP Deviations: Products not manufactured under current good manufacturing practices.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. M
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle wit
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Oun
Hazard: 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.
June 20, 2018DrugsFDA
MBi Distributing Inc. dba MBi Nutraceuticals recalls Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with gl
Hazard: 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.
June 20, 2018DrugsFDA
Inopak Ltd recalls Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Hazard: Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
June 20, 2018DrugsFDA
Shadow Holdings DBA Bocchi Labs recalls Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne S
Hazard: CGMP Deviations: products may be contaminated with bacteria.
June 20, 2018DrugsFDA
Shadow Holdings DBA Bocchi Labs recalls Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp
Hazard: CGMP Deviations: products may be contaminated with bacteria.
June 20, 2018DrugsFDA
Shadow Holdings DBA Bocchi Labs recalls Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp.,
Hazard: CGMP Deviations: products may be contaminated with bacteria.
June 20, 2018DrugsFDA
Shadow Holdings DBA Bocchi Labs recalls X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottle
Hazard: CGMP Deviations: products may be contaminated with bacteria.
June 20, 2018DrugsFDA
Medline Industries Inc (Northpoint Services) recalls READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by
Hazard: Microbial Contamination of a Non-Sterile Product.
June 20, 2018DrugsFDA
PharMEDium Services, LLC recalls HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC
Hazard: Superpotent and Subpotent
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharma
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Phar
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
June 20, 2018DrugsFDA
RIJ Pharmaceutical LLC recalls Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbri
Hazard: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.