0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18…
B BRAUN MEDICAL INC · Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Status
- Ongoing
- City
- Allentown
- State
- PA
- Country
- United States
- Classification
- Class I
- Product type
- Drugs
- Event ID
- 99703
- Recalling firm
- B BRAUN MEDICAL INC
- Address 1
- 861 Marcon Blvd
- Postal code
- 18109-9577
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0869-2026
- Product quantity
- 201,472 total container
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Recall initiation date
- 20260819
- Center classification date
- 20260922
- Report date
- 20260916
- Code info
- Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
- Product description
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
- Harmonized identifiers (openFDA)
- Application number
- NDA017464
- Brand name
- SODIUM CHLORIDE
- Generic name
- SODIUM CHLORIDE
- Manufacturer name
- B. Braun Medical Inc.
- Product NDC
- 0264-1800
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- SODIUM CHLORIDE
- RxCUI
- 1807630, 1807631, 1807632
- SPL ID
- 7d4ee37f-5016-422c-9f66-e675ae22c46a
- SPL set ID
- cc14fafd-3dcd-4fc8-bdbd-6f355c375768
- Package NDC
- 0264-1800-36, 0264-1800-31, 0264-1800-32
- Is original packager
- true
- UNII
- 451W47IQ8X