Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
Dr. Reddy's Laboratories recalled 571 vials of Succinylcholine Chloride Injection on September 26, 2025. The recall stems from out-of-specification results during stability testing, indicating a decreased preservative concentration. The product is used for intravenous or intramuscular administration and is available by prescription only.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Consumers and healthcare providers should stop using this product immediately. Contact Dr. Reddy's Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter
The recalled product is Succinylcholine Chloride Injection, USP, 200 mg/10 mL, distributed in 25 x 10 mL multiple-dose vials. The NDC number is 43598-666-25. This product was distributed nationwide.
The recall is due to out-of-specification results during six-month stability testing. The decreased preservative concentration raises concerns about the product's safety and efficacy.
No specific incidents or injuries have been reported related to this recall. The high hazard classification indicates potential serious risks.
Stop using the product immediately. Contact Dr. Reddy's Laboratories or your healthcare provider for further guidance.
For more information, call Dr. Reddy's Laboratories at their customer service line or visit their official website.
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date