Prescription and over-the-counter medications
Mylan Pharmaceuticals
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
MBi Distributing Inc.
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.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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.
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.
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.
Medline Industries Inc (Northpoint Services)
Microbial Contamination of a Non-Sterile Product.
CGMP Deviations: products may be contaminated with bacteria.
Contraceptive Tablets Out of Sequence.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: products may be contaminated with bacteria.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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.
MBi Distributing Inc.
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.
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
MBi Distributing Inc.
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.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products not manufactured under current good manufacturing practices.