Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Product description
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Lot numbers, UPCs & expiration codes
Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;
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-1409-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2016
- FDA report date
- Jul 27, 2016
- Quantity
- 435 Monoject Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1409-2016, 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
- Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;
- Postal code
- 60045-2506
- Report date
- Jul 27, 2016
- Product type
- Drugs
- Recall number
- D-1409-2016
- Classification
- Class II
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 435 Monoject Syringes
- 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
- 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
- Distribution pattern
- Nationwide
- Recall initiation date
- May 5, 2016
- Initial firm notification
- Center classification date
- Jul 16, 2016