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Class II · ModerateRecall completed

Gabapentin Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 7700656A
Where it was soldProduct was distributed in Mason, OH.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Distributed by / forSolco Healthcare US, LLC, Cranbury, NJ, 08512, USA
NDC43547-0333-50
Show the full FDA record
Full product labelGabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
Recalling firmSolco Healtcare US LLC
DistributionProduct was distributed in Mason, OH.
QuantityN/A
Recall initiated2017-12-04
Report date2018-01-17
Recall completed2019-02-25
Recall numberD-0155-2018
ClassificationClass II
FDA statusTerminated
Origin on fileCranbury NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.