Aurobindo Gabapentin Capsule Recall [US]


US FlagUS/Silver Spring: Aurobindo Pharma Gabapentin Capsule Recall [US]Aurobindo Pharma USA recalls Gabapentin Capsules, USP 300 mg due to reports of empty capsules, a serious health hazard. FDA: http://ht.ly/F6n8s 

Direct link: http://www.fda.gov/Safety/Recalls/ucm424470.htm

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

  • Gabapentin Capsules, packaged in 100-count bottles with a lot identification of GESB14011-A, an expiration date of 12/2015 and a drug ID of NDC 16714-662-01. The product can be identified by the imprint “D” on yellow cap and “03” on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.

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

According to the FDA, empty capsules could result in missed dose(s) of Gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or Status Epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall to date, but has received four (4) complaints for empty capsules.

Gabapentin is used as in the treatment of Epilepsy and for the management of Postherpetic Neuralgia (pain due to Shingles).

Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or PVG@aurobindousa.com Monday through Friday, 8:30 AM to 5:00 PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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Additional information about this recall:
Recalls Direct RIN: 4480-2014
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/
E. & O. E.

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