Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Cisatracurium Besylate Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.
Affected NDCs
71288-0712-05
71288-0712-06
Compare with the code on your package — it is the most precise check available.
Drug: Cisatracurium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cisatracurium Besylate NDC 71288-0712 |
10 mg/5mL | Injection, Solution Intravenous |
Meitheal Pharmaceuticals Inc. | Rx |
- Recalling firm
- Meitheal Pharmaceuticals Inc
- NDC code
- 71288-712-05
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0286-2021 · 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 Cisatracurium recalls
See all
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class II · Moderate risk
Cisatracurium Besylate Injection
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk
Cisatracurium Besylate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Meitheal Pharmaceuticals Inc
All 2021 recalls
Class II · Moderate risk
Cetrorelix Acetate for Injection
Defective Delivery System: Missing or duplicated needles within the injection kit
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications
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