Why it was recalled
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Product description
Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Lot numbers, UPCs & expiration codes
lot number 37-74693, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74693-0-4-R, Disp ID: 37-1124640
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-450-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 17, 2014
- FDA report date
- Apr 15, 2015
- Quantity
- 4 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-450-2015, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 70148
- Address
- 6580 Snowdrift Rd Ste 100
- Code information
- lot number 37-74693, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74693-0-4-R, Disp ID: 37-1124640
- Postal code
- 18106-9331
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-450-2015
- Classification
- Class I
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 4 bags
- Termination date
- Aug 19, 2015
- Reason for recall
- Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 17, 2014
- Initial firm notification
- Telephone
- Center classification date
- Apr 8, 2015