Golden State Medical Supply Recalls Duloxetine Capsules Due to Labeling Error
Golden State Medical Supply is recalling 2,077 bottles of Duloxetine 60 mg capsules because the container labels display an incorrect expiration date.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
Golden State Medical Supply Inc. is recalling 2,077 bottles of Duloxetine (Duloxetine Hydrochloride) Delayed-Release Capsules, USP, 60 mg. The product is a prescription-only medication manufactured by Laboratorios del Dr. Esteve, SA, and distributed nationwide in the United States. The recall involves specific lots identified as GS011709 and GS012352.
The recall was initiated due to a labeling error on the container. The expiration date printed on the label is 02/2019, but the correct expiration date is 02/2018. This discrepancy could lead to the use of expired medication.
Consumers and healthcare providers who have purchased or dispensed these specific bottles should stop using the product and contact their pharmacist or the recalling firm for instructions on return or replacement. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,077
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 (2)
- Lot# GS011709
- GS012352
Distribution
Distributed nationwide across the United States.
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