Additional information received on 11-Jun-2010
On April 30, 2010, McNeil initiated a voluntary recall of multiple liquid products manufactured at the Fort Washington facility that are within product shelf life. Some of these products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.
1. A total of 26 lots were manufactured with Avicel RC591 FMC (supplier) lot DN08819943 as an inactive ingredient in some lots of the following products: Children's Tylenol Suspension 4 oz. Cherry, Infants Tylenol Suspension Drop ½ oz. Grape, Infants Tylenol Dye Free Suspension Drop 1 oz. Cherry, Children's Tylenol + Cold Multi-symptom Suspension 4 oz. Grape, Tylenol Pediatric Cherry Suspension Hospital/Government 4 oz., Children's Tylenol Suspension 4 oz. Grape, Children's Tylenol Suspension 4 oz. Bubblegum, Tylenol Grape Suspension Drop Hospital/Government ½ oz., 15 ml package, Children Tylenol Dye Free Suspension 4 oz. Cherry, Children's Tylenol Suspension ½ Cherry, Children's Tylenol + Cold/Cough Dye Free Suspension 4 oz. Grape and Infant's Tylenol Suspension Drop 1 oz. Grape. Subsequent to release of these products to market, it was discovered the supplier had separated out a portion of the lot for the presence of gram negative organisms. That portion of the vendor lot was not shipped to McNeil nor used in production of finished product. Corrective actions had been previously implemented with the supplier. No additional corrective actions are needed.
2. 3 of 10 lots of Infant's Dye Free Tylenol Drops, Cherry manufactured utilizing a 1000 gallon mix and 1000 gallon hold tank were rejected for failure to meet the potency specification for samples pulled from the end of the batch. The 3 lots were not released to the market. However, this batch size utilizing the 1000 gallon mix and hold tanks will not be manufactured in the Fort Washington facility without re-assessing the batch size development and re-validation of the process.
3. Other lots may contain tiny particles. Investigation to date has revealed potential root causes to be the filling equipment used in production and some raw material. Corrective actions are being developed and will be implemented prior to production resuming.
In all cases, the products were voluntarily recalled as a precautionary measure.
Saturday, July 31, 2010
The Children's Tylenol Statement
This is the statement being appended to all adverse event reports related to the recall of children's products from McNeil's Ft Washington plant, including Children's Tylenol. No other comments here - PB will just take the Wikileak role. We report, you decide.