Prescription and over-the-counter medications
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
American Pharmaceutical Ingredients
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Spirit Pharmaceuticals
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Mckesson Packaging Services
Failed Stability Specifications
Hospira Inc. A Pfizer Company
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
AstraZeneca Pharmaceuticals
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Bella All Natural
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Bayer HealthCare Pharmaceuticals
Labeling: Label mix-up
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Osmotica Pharmaceutical
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
SCA Pharmaceuticals
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Oxygen Development
Superpotent drug: failed assay throughout the stick after 6 months stability.
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Presence of Particulate Matter; contains visible particulate matter identified as mold.