Medicine recalls
|
| |
| The United States: Novis PR LLC issues voluntary nationwide recall of PECGEN DMX due to a labeling error |
| |
The US Food and Drug Administration (FDA) announces that Novis PR LLC is voluntarily recalling 5 lots of PECGEN DMX, 16 oz, a liquid cough syrup to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
There is no evidence that cough and cold medicines are safe or effective for young children. However, there is evidence that children have been harmed by overdoses of these products. Problems include seizures, coma, and death. Dextromethorphan can also interact with Tylenol or other cough/cold medications to be highly toxic - more than if given alone. To date, Novis PR LLC has not received any reports of adverse events related to this recall.
The product is used as a cough suppressant and expectorant and is packaged in amber plastic 16 oz bottles in cases of 12 units. The affected PECGEN DMX lots include the following lot numbers and expiration dates: D80202 Exp 02/20, D80210 Exp 02/20, D80818 Exp 09/20, D80819 Exp 09/20, D80820 Exp 09/20.
Error was discovered by an email notification of an unidentified individual alerting of incorrect information in label.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-nationwide-recall-pecgen-dmx-due-labeling-error
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, May 31, 2019
Issued at HKT 15:00
|
| |
