Class II · Moderate risk
Dutasteride 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Dutasteride and Tamsulosin HCl Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.
Affected NDCs
0591-3771-19
0591-3771-30
Compare with the code on your package — it is the most precise check available.
Drug: Dutasteride
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0591-3771-30
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0069-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dutasteride recalls
See all
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Other recalls by Teva Pharmaceuticals USA
All 2017 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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