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.
All Recalls
95,075 total recalls in our database
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.
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
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.
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.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
PharMEDium Services
Superpotent and Subpotent
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
5F DL BIOFLO PASV, Catalog Number 60M141006
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
RS 5F DL BIOFLO PASV, Catalog Number 60M132324
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A shipment to Guadeloupe suffered a temperature excursions up to 47.8ΒΏC, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMΒΏrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
The implants are mislabeled.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8ΒΏC, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMΒΏrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
RS TANDEM 5F DL XPP, Catalog Number 60M019881
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).