Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product description
heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
Lot numbers, UPCs & expiration codes
Lot: 36-243555, 36-243556, Exp. 7/10/2023; 36-245117, 36-245118, 36-245119, 36-245120, Exp. 7/12/2023; 36-246163, 36-246164, Exp. 7/14/2023; 36-247010, Exp. 7/18/2023; 36-248226, 36-248229, 36-248232, 36-248248, Exp. 7/24/2023; 36-249829, 36-249830, 36-249831, 36-249832, Exp. 8/1/2023; 36-250047, 36-250048, 36-250049, 36-250050, Exp. 8/2/2023; 36-250289, 36-250290, 36-250291, 36-250293, Exp. 8/3/2023; 36-251057, 36-251058, 36-251060, Exp. 8/4/2023; 36-251385, 36-251386, 36-251387, 36-251388, Exp. 8/7/2023; 36-251448, 36-251449, 36-251450, Exp. 8/8/2023; 36-252462, Exp. 8/14/2023; 36-254679, 36-254681, Exp. 8/16/2023; 36-255116, 36-255117, 36-255118, Exp. 8/17/2023; 36-255488, Exp. 8/18/2023.
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-0978-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2023
- FDA report date
- Aug 9, 2023
- Quantity
- 11,824 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0978-2023, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 92707
- Address
- 2200 S 43rd Ave
- Code information
- Lot: 36-243555, 36-243556, Exp. 7/10/2023; 36-245117, 36-245118, 36-245119, 36-245120, Exp. 7/12/2023; 36-246163, 36-246164, Exp. 7/14/2023; 36-247010, Exp. 7/18/2023; 36-248226, 36-248229, 36-248232, 36-248248, Exp. 7/24/2023; 36-249829, 36-249830, 36-249831, 36-249832, Exp. 8/1/2023; 36-250047, 36-250048, 36-250049, 36-250050, Exp. 8/2/2023; 36-250289, 36-250290, 36-250291, 36-250293, Exp. 8/3/2023; 36-251057, 36-251058, 36-251060, Exp. 8/4/2023; 36-251385, 36-251386, 36-251387, 36-251388, Exp. 8/7/2023; 36-251448, 36-251449, 36-251450, Exp. 8/8/2023; 36-252462, Exp. 8/14/2023; 36-254679, 36-254681, Exp. 8/16/2023; 36-255116, 36-255117, 36-255118, Exp. 8/17/2023; 36-255488, Exp. 8/18/2023.
- Postal code
- 85043-3909
- Report date
- Aug 9, 2023
- Product type
- Drugs
- Recall number
- D-0978-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 11,824 bags
- Termination date
- Mar 28, 2025
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2023