Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Succinylcholine Chloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.
Affected NDCs
16729-0493-03
16729-0493-45
Compare with the code on your package — it is the most precise check available.
Drug: Succinylcholine
- Recalling firm
- Accord Healthcare, Inc.
- NDC code
- 16729-493-03
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0413-2023 · 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 Succinylcholine recalls
See all
Class II · Moderate risk
Succinylcholine Chloride Injection
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
succinylcholine
Lack of assurance of sterility:
Other recalls by Accord Healthcare, Inc.
All 2023 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.