Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31
Astral SteriTech Private
Lack of Assurance of Sterility
Prescription and over-the-counter medications
Astral SteriTech Private
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Product mixup: one foreign tablet found in product.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Family Dollar Stores
CGMP deviation: product outside labeled storage temperature requirements.
PD-Rx Pharmaceuticals
CGMP deviations.
Family Dollar Stores
CGMP deviation: product outside labeled storage temperature requirements.
PD-Rx Pharmaceuticals
CGMP deviations.
CGMP deviations.
Gadget Island
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Family Dollar Stores
CGMP deviation: product outside labeled storage temperature requirements.
Gadget Island
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
CGMP deviations.
CGMP deviations.
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Family Dollar Stores
CGMP deviation: product outside labeled storage temperature requirements.