The Recall Desk
LowFDA (Drugs)·D-0147-2017·Announced 2016-11-30

West-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel

West-Ward Pharmaceuticals is recalling 32,102 bottles of Amoxicillin oral suspension because some bottles are missing the color-coded panel that displays the product strength.

What this means for you

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, and the issue is a minor labeling error.

Plain-English summary

West-Ward Pharmaceuticals Corp. is recalling 32,102 bottles of Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted). The affected product is Lot # AS1466A, with an expiration date of January 2019. The product was distributed nationwide.

The recall was initiated due to a labeling error where some bottles are missing the color-coded panel where the product strength is typically displayed. This is a Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product
AMOXICILLIN (AMOXICILLIN)
Brand
AMOXICILLIN
Affected units
32,102

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)

  • Lot #: AS1466A
  • Exp. Jan 2019

UPCs (2)

  • 0301439887508
  • 0301439886501

Distribution

Distributed nationwide across the United States.