Why it was recalled
Sub-potent
Product description
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Lot numbers, UPCs & expiration codes
Lot: 183220013C Exp. 12/19/2018
Where it was sold
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-0333-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 5, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 295 50 ml in 60 ml syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0333-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81730
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot: 183220013C Exp. 12/19/2018
- Postal code
- 60045-2506
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0333-2019
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 295 50 ml in 60 ml syringes
- Termination date
- Oct 2, 2020
- Reason for recall
- Sub-potent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 5, 2018
- Initial firm notification
- Telephone
- Center classification date
- Dec 15, 2018