Rugby Labs Diocto Liquid & Syrup Recall [US]


US FlagUS/Silver Spring: Rugby Labs Diocto Liquid & Syrup Recall [US]Rugby Laboratories recalls all current batch/lots of Diocto Liquid and Diocto Syrup manufactured by PharmaTech, LLC due to suspected Burkholderia cepacia contamination and consequential bacterial infection, a serious health hazard. FDA: http://ht.ly/732730ec2uq

Direct link: https://www.fda.gov/Safety/Recalls/ucm569967.htm

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

  • Diocto Liquid, a stool softener sold in one pint (473 mL) bottles, with a recommended dosage of 50 mg/5 mL with an NDC of 0536-0590-85. All current batch/lots are affected by this recall.
  • Diocto Syrup, a stool softener sold in one pint (473 mL) bottles, with a recommended dosage of 60mg/15mL with an NDC of 0536-1001-85. All current batch/lots are affected by this recall.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. One (1) additional image of the recalled drugs can be found on the Web site above.

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

According to the FDA, Rugby Laboratories has recalled all lots within the expiry of Diocto Liquid and Diocto Syrup, (Docusate Sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia.

If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as Cystic Fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug, return it to your pharmacist for refund. Disposal of this product must be in accordance with local municipal hazardous waste requirements to protect the drinking water supply and the ecosystem. Please check with municipal waste authorities in your community regarding the safe disposal of this product.

If you have any questions about this recall, please contact Rugby’s Customer Support Department at 1-800-645-2158 from 8:00 AM to 8:00 PM Eastern Standard Time, Monday to Friday.

==> To see other recalls and notifications caused by suspected contaminated Laxatives, please search for “laxatives” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Burkholderia cepacia contamination, please search for “Burkholderia” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 9038-2017
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:
==> http://wp.me/P2bVty-2
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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