Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product description
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
Lot numbers, UPCs & expiration codes
Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;
Where it was sold
Nationwide
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-1421-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2016
- FDA report date
- Jul 27, 2016
- Quantity
- 2,256 Medical Cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1421-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74057
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;
- Postal code
- 60045-2506
- Report date
- Jul 27, 2016
- Product type
- Drugs
- Recall number
- D-1421-2016
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 2,256 Medical Cassettes
- Termination date
- Mar 6, 2018
- Reason for recall
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2016
- Initial firm notification
- Center classification date
- Jul 16, 2016