B BRAUN MEDICAL INC: 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 180
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The text below is copied from the official FDA (press release) record. If anything differs, the official notice is correct.
- Company / brand
- B BRAUN MEDICAL INC
- Product
- 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.
- Reason / hazard
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-08-19
- Product type
- Drugs,
- Code info
- Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
- Product quantity
- 201,472 total container
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Allentown
- State
- PA
- Country
- United States
- Event id
- 99703
- Enforcement url
- https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99703
- Enforcement id
- fda-drug-D-0869-2026
- Announced product
- 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
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