The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0211-2018·Announced 2018-01-17

Akorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer

Akorn Inc is recalling 4,885 bottles of Gabapentin Oral Solution because the product was released with an unapproved active ingredient manufacturer.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor compliance issues.

Plain-English summary

Akorn Inc is voluntarily recalling 4,885 bottles of Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle. The product is identified by Batch# 359774 and has an expiration date of 09/02/19. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the inadvertent release of a drug product with an unapproved active ingredient manufacturer.

The affected product was distributed nationwide. The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that the use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Manufacturer
Akorn Inc
Category
Drug — Prescription Medication
Hazard
Affected units
4,885

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 (2)

  • Batch# 359774
  • Exp. 09/02/19

Distribution

Distributed nationwide across the United States.

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