Class II · Moderate risk
N-Acetyl-L-Cysteine for Injection
Lack of Assurance of Sterility
L-Cysteine Hydrochloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Affected NDCs
66758-0005-01
66758-0005-02
Compare with the code on your package — it is the most precise check available.
Drug: Cysteine
- Recalling firm
- Sandoz Inc
- NDC code
- 66758-005-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0141-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cysteine recalls
See all
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class II · Moderate risk
N-A-C
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Class II · Moderate risk
5% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Other recalls by Sandoz Inc
All 2016 recalls
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class II · Moderate risk
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only
Temperature Abuse
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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