CLASS I Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Hyperlyte CR (Multi-Electrolyte Concentrate) Container recalled
B. Braun Medical is recalling Hyperlyte CR (Multi-Electrolyte Concentrate) Container, distributed nationwide in the US. The recall was initiated on 21 Nov 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1275-2014
- FDA event ID
- 66913
- Recalling firm
- B. Braun Medical, Irvine, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Nov 2013
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 21 Nov 2013 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +155 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide, Puerto Rico and Spain
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Which lots are affected?
Lot# J3B007, Exp 08/14
Where was it sold?
Nationwide, Puerto Rico and Spain
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 66913This product is part of a recall event; the main page for the event is Cefoxitin for Injection and Dextrose Injection in Duplex Container recalled.
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|---|---|---|---|---|---|
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