PECGEN DMX Cough Syrup Recall [US]


PECGEN DMX Cough Syrup Recall [US]

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US FlagUS/Silver Spring: NOVIS PR LLC, a Rio Piedras, Puerto Rico establishment, recalls an estimated five (5) batch/lots of PECGEN DMX Cough Syrup due to suspected incorrect dosage information on its label and consequential risk of overdose producing seizures, coma and death, all serious health hazards.

FDA: http://ht.ly/XSof30oRByQ

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-nationwide-recall-pecgen-dmx-due-labeling-error

Additional information:
The US Food and Drug Administration (“FDA”) reports the following drugs are subject to this recall:

  • PECGEN DMX Cough Syrup, sold in 16 ounce bottles, a DIN of NDC 52083-630-16 and the following expiration dates: D80202 Exp date 02/20, D80210 Exp 02/20, D80818 Exp 09/20, D80819 Exp 09/20, D80820 Exp 09/20.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, the recall was initiated after it was found the its packaging provided incorrect dosage information on its label due to a typographical error. The drug facts label, available at the Web site above, incorrectly states “children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician”.

The label should actually 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.. You should neither serve nor consume the recalled PRODUCTS identified above.

PECGEN DMX was distributed in Puerto Rico to wholesalers and retail pharmacies. The recalled Cough Syrup is known to have been sold only in Puerto Rico.

If you believe you have purchased or have in your possession any of the recalled drug, please do not consume them directly nor use them as an ingredient in another preparation. Instead, return the Cough Syrup to the store where you purchased it for a full refund.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle overdoses.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Cough Syrup, please search for “cough syrup” or more generically, “drug” using the Search Box at the top of this page.

If you have any questions about this recall, please contact Novis PR LLC at 1-787-767-2072 from 7:30 AM to 4:30 PM Atlantic Standard Time, Monday to Friday. You can also reach the company by e-mail at info@kramernovis.com.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by NOVIS PR LLC, please search for “NOVIS” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11558-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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