Why it was recalled
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Product description
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
Lot numbers, UPCs & expiration codes
Lot, exp: 170615-004, 9/13/2017; 170720-009, 10/18/2017
Where it was sold
SSM Health entities in the state of MO only
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-0139-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2017
- FDA report date
- Jan 3, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
Original FDA data
Every field from FDA enforcement report D-0139-2018, exactly as published.
Show all FDA fields
- City
- Fenton
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 78678
- Address
- 1015 Bowles Ave
- Code information
- Lot, exp: 170615-004, 9/13/2017; 170720-009, 10/18/2017
- Postal code
- 63026-2394
- Report date
- Jan 3, 2018
- Product type
- Drugs
- Recall number
- D-0139-2018
- Classification
- Class II
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Termination date
- Mar 22, 2018
- Reason for recall
- Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
- Distribution pattern
- SSM Health entities in the state of MO only
- Recall initiation date
- Aug 10, 2017
- Initial firm notification
- Center classification date
- Dec 28, 2017