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
NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
Lot numbers, UPCs & expiration codes
Lot # 37-882998, 37-883005, 37-883145, Exp 04/28/2023; 37-883144, 37-883220, 37-883221, 37-883222, Exp 04/30/2023; 37-883925, Exp 05/02/2023; 37-884180, 37-884181, Exp 05/03/2023; 37-884505, 37-884506, 37-884507, 37-884508, 37-884509, Exp 05/04/2023; 37-884834, 37-884869, 37-884870, Exp 05/07/2023; 37-886058, Exp 05/10/2023; 37-886536, 37-886537, Exp 05/14/2023; 37-887062, 37-887389, Exp 05/15/2023; 37-887784, 37-887787, Exp 05/17/2023; 37-888029, 37-888048, Exp 05/18/2023; 37-888261, 37-888263, 37-888269, 37-888282, 37-888292, 37-888294, 37-888301, 37-888302, Exp 05/21/2023; 37-890058, 37-890064, 37-890074, 37-890076, Exp 05/28/2023; 37-891747, 37-891748, 37-891750, 37-891751, 37-891753, Exp 06/04/2023; 37-893530, 37-893531, 37-893532, Exp 06/11/2023; 37-894760, 37-894761, Exp 06/14/2023; 37-894988, 37-894990, Exp 06/15/2023; 37-896260, Exp 06/20/2023; 37-896621, Exp 06/21/2023; 37-898518, 37-898519, Exp 06/29/2023; 37-898789, 37-898790, 37-898791, 37-898792, 37-898793, Exp 07/02/2023; 37-899718, Exp 07/04/2023; 37-900591, 37-900596, Exp 07/09/2023; 37-901149, Exp 07/10/2023
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-0734-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 28, 2023
- FDA report date
- May 31, 2023
- Quantity
- 6341 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
Original FDA data
Every field from FDA enforcement report D-0734-2023, 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 # 37-882998, 37-883005, 37-883145, Exp 04/28/2023; 37-883144, 37-883220, 37-883221, 37-883222, Exp 04/30/2023; 37-883925, Exp 05/02/2023; 37-884180, 37-884181, Exp 05/03/2023; 37-884505, 37-884506, 37-884507, 37-884508, 37-884509, Exp 05/04/2023; 37-884834, 37-884869, 37-884870, Exp 05/07/2023; 37-886058, Exp 05/10/2023; 37-886536, 37-886537, Exp 05/14/2023; 37-887062, 37-887389, Exp 05/15/2023; 37-887784, 37-887787, Exp 05/17/2023; 37-888029, 37-888048, Exp 05/18/2023; 37-888261, 37-888263, 37-888269, 37-888282, 37-888292, 37-888294, 37-888301, 37-888302, Exp 05/21/2023; 37-890058, 37-890064, 37-890074, 37-890076, Exp 05/28/2023; 37-891747, 37-891748, 37-891750, 37-891751, 37-891753, Exp 06/04/2023; 37-893530, 37-893531, 37-893532, Exp 06/11/2023; 37-894760, 37-894761, Exp 06/14/2023; 37-894988, 37-894990, Exp 06/15/2023; 37-896260, Exp 06/20/2023; 37-896621, Exp 06/21/2023; 37-898518, 37-898519, Exp 06/29/2023; 37-898789, 37-898790, 37-898791, 37-898792, 37-898793, Exp 07/02/2023; 37-899718, Exp 07/04/2023; 37-900591, 37-900596, Exp 07/09/2023; 37-901149, Exp 07/10/2023
- Postal code
- 18106-9331
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0734-2023
- Classification
- Class II
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Product quantity
- 6341 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
- NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Apr 28, 2023
- Initial firm notification
- Center classification date
- May 19, 2023