Prescription and over-the-counter medications
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Superpotent Drug: high out-of-specification result for magnesium.
Mckesson Packaging Services
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Noven Pharmaceuticals
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Presence of foreign substance: glass particle
Hospira Inc., A Pfizer Company
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
CGMP Deviations
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Complete Pharmacy and Medical Solutions
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Safecor Health
CGMP Deviations
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
American Pharmaceutical Ingredients
cGMP Deviations; lack of quality assurance.
Complete Pharmacy and Medical Solutions
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.