Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Reported: November 8, 2017 Initiated: October 6, 2017 #D-0055-2018
Product Description
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Reason for Recall
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 274 cartons
- Distribution
- Nationwide in the USA
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.. Recalled by AVKARE Inc.. Units affected: 274 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0055-2018.
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