Why it was recalled
Discoloration; Hazy solution found in one vial instead of a clear solution.
Product description
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Lot numbers, UPCs & expiration codes
Lot CFD190004, exp. date August 2020
Where it was sold
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
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-0609-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2019
- FDA report date
- Dec 11, 2019
- Quantity
- 59,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0609-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84244
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot CFD190004, exp. date August 2020
- Postal code
- 08520-1401
- Report date
- Dec 11, 2019
- Product type
- Drugs
- Recall number
- D-0609-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 59,500 vials
- Termination date
- Jan 21, 2021
- Reason for recall
- Discoloration; Hazy solution found in one vial instead of a clear solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
- Distribution pattern
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
- Recall initiation date
- Nov 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2019