Drug product
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
D-0008-2026
Product summary
- Event
- Event 97690
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 571 vials
- Official record key
drug-enforcement:D-0008-2026
Official wording
Reason: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Code information: Lot # K250048
Distribution pattern: Nationwide within the USA.
Derived failure modes
-
Potency or specification failure
Out-of-Specification