Recalls / Class III
Class IIID-1255-2016
Product
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 60429-164, 60429-165, 60429-166
- FDA application
- ANDA203088
- Affected lot / code info
- Lot# GS011709, GS012352
Why it was recalled
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 2077 bottles
- Distribution pattern
- Nationwide. No foreign distribution.
Timeline
- Recall initiated
- 2016-06-28
- FDA classified
- 2016-07-11
- Posted by FDA
- 2016-07-20
- Terminated
- 2016-11-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1255-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.