Eptifibatide Injection recall: Impurity Out of Spec
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake…
Why was Eptifibatide Injection recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: 091287A, 091377A, Exp. 9/19.
- Product
- Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake…
- Recalling firm
- Akorn, Inc.
- Quantity
- 4085 vials
- Distribution
- Nationwide in the U.S.
- Recall date
- September 4, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)