Duloxetine Prescription Capsules Recalled Nationwide for Nitrosamine Impurity
Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—nitrosamine impurity above safety limits—is a risk-of-harm concern but remains theoretical without adverse health reports, meeting the criterion for Score 3 (High).
Plain-English summary
Golden State Medical Supply Inc. is recalling Duloxetine (Duloxetine Hydrochloride) 30mg delayed-release capsules nationwide due to the presence of N-nitroso-duloxetine, a nitrosamine drug substance related impurity (NDSRI), in excess of the FDA's proposed interim limit. The affected lots are GS045371 and GS045910, both expiring January 31, 2025.
Nitrosamines are substances that may have carcinogenic potential. The impurity was found to exceed established safety thresholds during manufacturing quality control. This recall addresses a manufacturing and quality control deviation rather than a safety incident with reported patient harm.
The recall affects Duloxetine capsules distributed nationwide in the United States in two package sizes: 30-capsule bottles (NDC 60429-165-30) and 90-capsule bottles (NDC 60429-165-90). Approximately 55,804 units are affected.
Consumers and healthcare providers who have the affected medication should consult their healthcare provider about the recall before stopping the medication, as abrupt discontinuation may cause withdrawal symptoms.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Hazard
- nitrosamine-impurity
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 (4)
- Lot: a) GS045371
- Exp: 01/31/2025
- b) GS045910
- Exp. 01/31/2025
Distribution
Distributed nationwide across the United States.
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