Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
💉
Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
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.
Silver-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
MBi Distributing Inc.
Class I - Dangerous
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 I - Dangerous
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Teething 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
MBi Distributing Inc.
Class I - Dangerous
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 I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
Shoreside Enterprises
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Milbar Laboratories
Class I - Dangerous
Subpotent
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Stability Specifications
Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Milbar Laboratories
Class I - Dangerous
Subpotent
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
Milbar Laboratories
Class I - Dangerous
GMP Deviations
Class I - Dangerous
Failed Stability Specifications
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Milbar Laboratories
Class I - Dangerous
GMP Deviations
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Milbar Laboratories
Class I - Dangerous
Microbial Contamination of Non-sterile Product