Drug & medication recalls Moderate risk

Solco Healtcare US LLC recalls Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcar…

Recall date
December 4, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0155-2018
FDA classification
Class II
Brand / firm
Solco Healtcare US LLC
Sold / distributed
Product was distributed in Mason, OH.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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