Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL…
Pfizer · Lack of Assurance of Sterility
- Status
- Ongoing
- City
- Manhattan
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99824
- Recalling firm
- Pfizer
- Address 1
- 66 Hudson Blvd
- Address 2
- N/A
- Postal code
- 10001-2189
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
- Recall number
- D-0853-2026
- Product quantity
- N/A
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation date
- 20260904
- Center classification date
- 20260917
- Report date
- 20260923
- Code info
- Lot # NL5230, Exp Date:10/2027
- Product description
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.
- Harmonized identifiers (openFDA)
- Application number
- NDA018132
- Brand name
- DOPAMINE HYDROCHLORIDE
- Generic name
- DOPAMINE HYDROCHLORIDE
- Manufacturer name
- Hospira, Inc.
- Product NDC
- 0409-5820, 0409-9104
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- DOPAMINE HYDROCHLORIDE
- RxCUI
- 1743938, 1743941
- SPL ID
- 7a125e39-1ecb-4c76-931a-efc9b5921d1c
- SPL set ID
- 1f306ad2-3606-4525-5a8a-ce78f426c1a2
- Package NDC
- 0409-5820-11, 0409-5820-01, 0409-9104-21, 0409-9104-20
- Is original packager
- true
- UNII
- 7L3E358N9L