Why it was recalled
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Product description
heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
Lot numbers, UPCs & expiration codes
Lot # 37-888633, 37-888637, 37-888641, 37-888658, 37-888666, 37-888839, Exp 05/02/2023; 37-890332, 37-890383, 37-890394, 37-890424, 37-890428, 37-890442, Exp 05/09/2023; 37-892010, 37-892021, 37-892046, 37-892061, 37-892116, 37-892120, 37-892150, 37-892153, Exp 05/16/2023; 37-893467, 37-893469, 37-893470, 37-893471, 37-893508, 37-893512, 37-893519, Exp 05/22/2023; 37-893925, 37-893937, 37-893939, 37-893940, 37-893958, 37-893968, Exp 05/23/2023; 37-895218, 37-895220, 37-895224, 37-895231, 37-895236, 37-895305, 37-895306, Exp 05/29/2023; 37-895754, 37-895756, 37-895757, Exp 05/30/2023
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-0731-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 11117 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0731-2023, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 92253
- Address
- 6580 Snowdrift Rd Ste 100
- Code information
- Lot # 37-888633, 37-888637, 37-888641, 37-888658, 37-888666, 37-888839, Exp 05/02/2023; 37-890332, 37-890383, 37-890394, 37-890424, 37-890428, 37-890442, Exp 05/09/2023; 37-892010, 37-892021, 37-892046, 37-892061, 37-892116, 37-892120, 37-892150, 37-892153, Exp 05/16/2023; 37-893467, 37-893469, 37-893470, 37-893471, 37-893508, 37-893512, 37-893519, Exp 05/22/2023; 37-893925, 37-893937, 37-893939, 37-893940, 37-893958, 37-893968, Exp 05/23/2023; 37-895218, 37-895220, 37-895224, 37-895231, 37-895236, 37-895305, 37-895306, Exp 05/29/2023; 37-895754, 37-895756, 37-895757, Exp 05/30/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0731-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 11117 bags
- Termination date
- Jun 22, 2025
- Reason for recall
- Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023