Lake Forest, Illinois-based injectable drug maker Hospira Inc. (HSP: Quote), Thursday revealed a voluntary user level recall of one lot of Hydromorphone Injection owing to complaint of a single Carpuject containing more than the 1 mL labeled fill volume.
The single-lot recall pertains to Hydromorphone Injection, USP, 2 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30.
The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system and comes with the lot number 12720LL. The expiration date is December 1, 2013. The affected lot was distributed in March - May 2012.
According to Hospira, an overdose of opioid pain medications like Hydromorphone can be life threatening and result in conditions such as respiratory depression, low blood pressure and reduced heart rate including circulatory collapse.
Hospira earlier in May had notified healthcare professionals regarding the potential of overfill in the pre-filled Carpuject Syringe System, as some syringes may contain more medication than is stated on the label.
Hospira has not received any reports of adverse events related to this issue for this lot. Anyone with an existing inventory should stop use and distribution, quarantine the product.
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by RTT Staff Writer
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