Drugs Recalls

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

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.

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

CGMP deviations: Ibuprofen is being recalled in response to previous recall

Failed Stability Specifications

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.

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.

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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.

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.

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

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

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.