PlainRecalls
FDA Drug Moderate Class II Terminated

Gabapentin 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

Reported: January 17, 2018 Initiated: December 4, 2017 #D-0155-2018

Product Description

Gabapentin 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

Reason for Recall

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

Details

Recalling Firm
Solco Healtcare US LLC
Units Affected
N/A
Distribution
Product was distributed in Mason, OH.
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
Gabapentin 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. Recalled by Solco Healtcare US LLC. Units affected: N/A.
Why was this product recalled?
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Which agency issued this recall?
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0155-2018.