Why it was recalled
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Product description
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
Lot numbers, UPCs & expiration codes
Lot# J3B007, Exp 08/14
Where it was sold
Nationwide, Puerto Rico and Spain
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-1275-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 21, 2013
- FDA report date
- May 7, 2014
- Quantity
- 5,592 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-1275-2014, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 66913
- Address
- 2525 McGaw Ave
- Code information
- Lot# J3B007, Exp 08/14
- Postal code
- 92614-5841
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1275-2014
- Classification
- Class I
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 5,592 units
- Termination date
- Dec 4, 2014
- Reason for recall
- Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
- Distribution pattern
- Nationwide, Puerto Rico and Spain
- Recall initiation date
- Nov 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2014