West-Ward Recalls Oxcarbazepine Oral Suspension Due to Impurity Failures
West-Ward Columbus Inc is recalling specific lots of Oxcarbazepine Oral Suspension because they failed impurity and degradation specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the failure of impurity specifications in a prescription medication.
Plain-English summary
West-Ward Columbus Inc is voluntarily recalling 32,347 bottles of Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle. The product is distributed by West-Ward Pharmaceuticals in Eatontown, NJ, and carries the NDC 0054-0199-59.
The recall was initiated because the affected lots failed impurity and degradation specifications. The specific lots involved are AA3957A and AA3958A, which expire in May 2020, and Lot AA5164A, which expires in September 2020.
These products were distributed nationwide in the United States and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the medication should be discontinued and returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 32,347
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 (6)
- Lot
- expiry: Lots AA3957A
- AA3958A
- exp May 2020
- Lot AA5164A
- exp Sep 2020
Distribution
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