Complete FDA and NHTSA recall records dated in December 2014.
These records include useful source details for the selected month.
Equipment malfunction led to ingredients to be blended at levels that are inconsistent with approved formulations.
The firm did not list food color, FD & C yellow #5, on the label.
HyVee Cheddar Cheese Stuffed Jalapenos is recalled due to undeclared egg.
The ice cream product may contain peanuts not listed on the ingredient statement.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure…
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to…
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to…
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to…
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure…
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved…
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure…
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
