Why it was recalled
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Product description
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
Lot numbers, UPCs & expiration codes
Lot 081887A, EXP 08/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1258-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 25, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 15,170 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-1258-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 85239
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot 081887A, EXP 08/2021
- Postal code
- 60045-4862
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1258-2020
- Classification
- Class III
- Recalling firm
- Akorn Inc
- Product quantity
- 15,170 ampules
- Termination date
- Jul 28, 2022
- Reason for recall
- Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 25, 2020
- Initial firm notification
- Letter
- Center classification date
- May 1, 2020