West-Ward Recalls Amoxicillin Oral Suspension Due to Labeling Error
West-Ward Pharmaceuticals is recalling specific lots of Amoxicillin For Oral Suspension because the bottles are missing the colored panel that displays the product strength.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling defect rather than a contamination or dosage error.
Plain-English summary
West-Ward Pharmaceuticals Corp. is recalling 32,006 bottles of Lot AS1413A and 32,198 bottles of Lot AS1414A of Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL. The product is distributed nationwide and has an expiration date of 11/18.
The recall was initiated due to a labeling error where the bottles are missing the colored coded panel that displays the strength of the product. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Consumers who have these specific lots of the medication should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
- Manufacturer
- West-Ward Pharmaceuticals Corp.
- Category
- Drug — Antibiotic
- 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 (3)
- Lot #: AS1413A
- AS1414A
- Exp. 11/18
Distribution
Distributed nationwide across the United States.
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