AvKARE Recalls Duloxetine Capsules Due to Slightly Elevated Phthalic Acid
AvKARE is recalling 274 cartons of Duloxetine Delayed-release Capsules 20 mg due to slightly elevated levels of phthalic acid.
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, and the source text explicitly states that no illnesses or injuries have been reported, with the hazard described as 'slightly elevated' levels of a degradation product, fitting the criteria for a moderate severity score.
Plain-English summary
AvKARE, Inc. is recalling 274 cartons of Duloxetine Delayed-release Capsules USP, 20 mg, manufactured for AvKARE, Inc. The product is identified by NDC 50268-283-15, Lot 18103, and an expiration date of 11/18. The recall was initiated because the product failed impurities and degradation specifications, specifically showing slightly elevated levels of phthalic acid.
The affected product was distributed nationwide in the USA. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 274
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: 18103 Exp. 11/18
Distribution
Distributed nationwide across the United States.
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