Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Reason Lack of sterility assurance.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
My Way
Reason Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk Terminated
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Reason Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Class II · Moderate risk Terminated
screamin' menthol
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
screamin' hot
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk Terminated
Silver-Zinc Throat Spray
Reason 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.
Class II · Moderate risk Terminated
Argentum Elixir Colloidal Silver
Reason 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.
Class II · Moderate risk Terminated
Expectorant Cough Syrup
Reason 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.
Class II · Moderate risk Terminated
Stomach Calm
Reason 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.
Class II · Moderate risk Terminated
Intestinal Colic Drops
Reason 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.
Class II · Moderate risk Terminated
Nausea Drops
Reason 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.
Class II · Moderate risk Terminated
Teething Drops
Reason 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.
Class II · Moderate risk Terminated
Scopolamine Transdermal Therapeutic System
Reason Defective delivery system
Class II · Moderate risk Terminated
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
Gericare Diocto Liquid
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
SDA Senna Syrup
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
Geritrex Senna Syrup
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
Ritussin DM Dextromethorphan Hydrobormide
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
GeriCare Senna Syrup
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
RPC APAP Elixir
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
RPC Children's Non-Aspirin
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated
RPC Senna Syrup
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.