AvKARE Recalls Dutasteride Capsules Due to Impurity Specification Failures
AvKARE Inc. is recalling specific lots of Dutasteride Capsules, 0.5 mg, 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 source text identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving chemical specification failures that may cause adverse health consequences.
Plain-English summary
AvKARE Inc. is voluntarily recalling 3,989 cartons of Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton. The affected product is prescription-only and was distributed nationwide in the USA. The recall involves three specific lots: 25246 (Exp. 02/2021), 24532 (Exp. 10/2020), and 23647 (Exp. 06/2020).
The recall was initiated because the product failed impurities and degradation specifications, specifically showing high out-of-specification results for related compounds. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their inventory for the specific NDC 50268-282-13 and the lot numbers listed above. If the product matches these details, it should be discontinued and returned to the distributor or manufacturer for credit. Consumers should consult their healthcare provider for alternative treatment options if they are currently using this medication.
The recalled product
- Product
- Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,989
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)
- Lots: 25246
- Exp. 02/2021
- 24532
- Exp. 10/2020
- 23647
- Exp. 06/2020
Distribution
Distributed nationwide across the United States.
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