Food, drugs, devices › AVKARE Inc.
Drug recall: Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski
FDA enforcement event 84677 is a drug recall by AVKARE Inc. of Pulaski, TN, initiated 7 Jan 2020 and classified Class II, with 1 product record.
FDA defines Class II as 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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 14 Jul 2021. Initiation: voluntary: firm initiated. AVKARE Inc. has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AVKARE Inc., Pulaski, TN.
Reason for recall
"Failed Impurities/Degradation Specifications: High out of specification results for related compounds."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0661-2020 | 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. | 3,989 cartons | Class II | Terminated | 22 Jan 2020 |
Context
Other enforcement events for AVKARE Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: High out of specification results for related compounds."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.