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
Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
Lot numbers, UPCs & expiration codes
Lot # 37-884108, 37-884109, Exp 05/03/2023; 37-884957, Exp 05/07/2023; 37-885047, 37-885048, Exp 05/08/2023; 37-885919, Exp 05/10/2023; 37-889426, 37-889432, Exp 05/24/2023; 37-891933, Exp 06/05/2023; 37-894274, Exp 06/13/2023; 37-896048, 37-896049, Exp 06/20/2023; 37-897798, Exp 06/27/2023
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-0752-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 3326 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0752-2023, 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 # 37-884108, 37-884109, Exp 05/03/2023; 37-884957, Exp 05/07/2023; 37-885047, 37-885048, Exp 05/08/2023; 37-885919, Exp 05/10/2023; 37-889426, 37-889432, Exp 05/24/2023; 37-891933, Exp 06/05/2023; 37-894274, Exp 06/13/2023; 37-896048, 37-896049, Exp 06/20/2023; 37-897798, Exp 06/27/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0752-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 3326 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
- Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023