Reason: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Distributed: Nationwide in the US MarketReason: Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Distributed: Nationwide in the USAReason: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Distributed: Nationwide in the USA.Reason: Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Distributed: Nationwide in the USA.Reason: Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
Distributed: Nationwide in the USA.Reason: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Distributed: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distributed: Firm failed to provide distribution pattern information.Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Distributed: Nationwide in the USAReason: Lack of assurance of sterility
Distributed: USA NationwideReason: Lack of assurance of sterility
Distributed: USA Nationwide