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
vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
Lot numbers, UPCs & expiration codes
Lot # 37-883407, 37-883436, Exp 05/01/2023; 37-883796, 37-883797, 37-883800, 37-883802, 37-883806, Exp 05/02/2023; 37-884162, 37-884163, Exp 05/03/2023; 37-885332, 37-885336, 37-885337, Exp 05/08/2023; 37-885749, 37-885753, 37-885755, Exp 05/09/2023; 37-886008, 37-886027, 37-886031, 37-886035, Exp 05/10/2023; 37-886273, 37-886274, 37-886275, Exp 05/11/2023; 37-887448, 37-887457, Exp 05/16/2023; 37-887765, 37-887772, 37-887775, Exp 05/17/2023; 37-888062, 37-888072, Exp 05/18/2023; 37-888811, 37-888817, Exp 05/22/2023; 37-889193, 37-889208, 37-889210, Exp 05/23/2023; 37-889450, 37-889451, 37-889454, Exp 05/24/2023; 37-890940, 37-890941, 37-890952, Exp 05/30/2023; 37-891137, 37-891138, 37-891139, Exp 05/31/2023; 37-892633, 37-892634, 37-892635, Exp 06/06/2023; 37-892934, 37-892961, 37-892964, 37-892965, Exp 06/07/2023; 37-893524, Exp 06/11/2023; 37-893993, 37-893996, Exp 06/12/2023; 37-894465, 37-894466, 37-894467, 37-894468, Exp 06/13/2023; 37-894706, 37-894714, Exp 06/14/2023; 37-895680, 37-895682, Exp 06/19/2023; 37-896123, Exp 06/20/2023; 37-896564, 37-896579, 37-896586, Exp 06/21/2023
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-0720-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 27780 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0720-2023, 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 # 37-883407, 37-883436, Exp 05/01/2023; 37-883796, 37-883797, 37-883800, 37-883802, 37-883806, Exp 05/02/2023; 37-884162, 37-884163, Exp 05/03/2023; 37-885332, 37-885336, 37-885337, Exp 05/08/2023; 37-885749, 37-885753, 37-885755, Exp 05/09/2023; 37-886008, 37-886027, 37-886031, 37-886035, Exp 05/10/2023; 37-886273, 37-886274, 37-886275, Exp 05/11/2023; 37-887448, 37-887457, Exp 05/16/2023; 37-887765, 37-887772, 37-887775, Exp 05/17/2023; 37-888062, 37-888072, Exp 05/18/2023; 37-888811, 37-888817, Exp 05/22/2023; 37-889193, 37-889208, 37-889210, Exp 05/23/2023; 37-889450, 37-889451, 37-889454, Exp 05/24/2023; 37-890940, 37-890941, 37-890952, Exp 05/30/2023; 37-891137, 37-891138, 37-891139, Exp 05/31/2023; 37-892633, 37-892634, 37-892635, Exp 06/06/2023; 37-892934, 37-892961, 37-892964, 37-892965, Exp 06/07/2023; 37-893524, Exp 06/11/2023; 37-893993, 37-893996, Exp 06/12/2023; 37-894465, 37-894466, 37-894467, 37-894468, Exp 06/13/2023; 37-894706, 37-894714, Exp 06/14/2023; 37-895680, 37-895682, Exp 06/19/2023; 37-896123, Exp 06/20/2023; 37-896564, 37-896579, 37-896586, Exp 06/21/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0720-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 27780 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
- vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023