Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
LACTATED RINGER'S Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Affected NDC
0409-7953-09
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- ICU Medical Inc
- NDC code
- 0409-7953-09
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1270-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by ICU Medical Inc
All 2020 recalls
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Other particulate / foreign matter recalls from 2020
All particulate / foreign matter recalls
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
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