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FDA Drug Recalls

17,898 recalls, newest first

Class II · Moderate risk Terminated May 15, 2018

Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass…

Reason Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach…

MBi Distributing Inc. dba MBi Nutraceuticals D-0867-2018

Class II · Moderate risk Terminated May 11, 2018

Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c)…

Reason Defective delivery system

L. Perrigo Company NDC 45802-580-84 D-0816-2018

Class I · High risk Terminated May 8, 2018

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira…

Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. NDC 60505-0688-4 D-0840-2018

Class I · High risk Terminated May 8, 2018

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira…

Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. NDC 60505-0687-4 D-0839-2018

Class II · Moderate risk Terminated May 7, 2018

Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57896-709-16 D-0853-2018

Class II · Moderate risk Terminated May 7, 2018

Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57896-403-16 D-0852-2018

Class II · Moderate risk Terminated May 7, 2018

SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 66424-562-08 D-0851-2018

Class II · Moderate risk Terminated May 7, 2018

Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 54162-007-08 D-0850-2018

Class II · Moderate risk Terminated May 7, 2018

Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0849-2018

Class II · Moderate risk Terminated May 7, 2018

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 57696-452-08 D-0848-2018

Class II · Moderate risk Terminated May 7, 2018

RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-129-16 D-0847-2018

Class II · Moderate risk Terminated May 7, 2018

Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0846-2018

Class II · Moderate risk Terminated May 7, 2018

RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-129-04 D-0845-2018

Class II · Moderate risk Terminated May 7, 2018

RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0844-2018

Class II · Moderate risk Terminated May 7, 2018

Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC D-0843-2018

Class II · Moderate risk Terminated May 7, 2018

Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged…

Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

RIJ Pharmaceutical LLC NDC 53807-158-12 D-0842-2018

Class II · Moderate risk Terminated May 7, 2018

Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo…

Reason Failed Stability Specifications

Perrigo New York NDC 45802-014-02 D-0817-2018

Class II · Moderate risk Terminated May 4, 2018

Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC…

Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches…

Noven Pharmaceuticals, Inc. NDC 68968-6637-1 D-0863-2018

Class II · Moderate risk Terminated May 4, 2018

Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC…

Reason Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches…

Noven Pharmaceuticals, Inc. NDC 68968-6610-1 D-0862-2018

Class III · Low risk Terminated May 4, 2018

Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

Reason Subpotent

Milbar Laboratories, Inc. D-0833-2018

Class III · Low risk Terminated May 4, 2018

T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic…

Reason Subpotent

Milbar Laboratories, Inc. D-0832-2018

Class II · Moderate risk Terminated May 4, 2018

MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN

Reason GMP Deviations

Milbar Laboratories, Inc. D-0814-2018

Class II · Moderate risk Terminated May 4, 2018

Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.

Reason GMP Deviations

Milbar Laboratories, Inc. D-0813-2018

Class II · Moderate risk Terminated May 4, 2018

Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by…

Reason GMP Deviations

Milbar Laboratories, Inc. D-0812-2018

Class II · Moderate risk Terminated May 4, 2018

B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Reason Microbial Contamination of Non-sterile Product

Milbar Laboratories, Inc. D-0811-2018