Succinylcholine Chloride Injection
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
Compare with the code on your package — it is the most precise check available.
Drug: Succinylcholine
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 |
|---|---|---|---|---|
| Succinylcholine NDC 43598-0666 |
CHLORIDE 20 mg/mL | Injection, Solution Intramuscular|intravenous |
Dr.Reddy's Laboratories Inc., | Rx |
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.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility:
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Failed Impurities/Degradation Specifications
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