Solco Healthcare Recalls Gabapentin Tablets Due to Labeling Error
Solco Healthcare is recalling Gabapentin 800 mg tablets because some bottles contain 600 mg tablets. The error affects product distributed in Mason, Ohio.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or severe injuries are reported in the source text, and the hazard is a labeling mix-up.
Plain-English summary
Solco Healthcare US, LLC is recalling Gabapentin Tablets, USP, 800 mg, 500-count, NDC 43547-0333-50, Lot # 7700656A. The recall is due to a labeling error where some bottles labeled as containing 800 mg tablets actually contain 600 mg tablets.
The affected product was distributed in Mason, Ohio. The recall is classified as Class II by the FDA, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their inventory for the specific lot number and NDC listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer for credit.
The recalled product
- Product
- 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
- Manufacturer
- Solco Healtcare US LLC
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 7700656A
Distribution
Distribution scope not specified by the agency.
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