The Recall Desk
ModerateFDA (Drugs)·D-0413-2023·Announced 2023-03-08

Accord Recalls Succinylcholine Chloride Injection Due to Manufacturing Deviations

Accord Healthcare is recalling Succinylcholine Chloride Injection due to manufacturing practice deviations discovered during FDA inspection. The recall affects 48,089 cartons distributed to the U.S., Puerto Rico, and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations discovered during inspection, with no reported illnesses or injuries. The precautionary nature of the recall and lack of specific hazard details, combined with FDA's Class II classification indicating remote probability of serious consequence, support moderate rather than high severity.

Plain-English summary

Accord Healthcare, Inc. is recalling Succinylcholine Chloride Injection, USP (200 mg/10 mL) due to manufacturing practice deviations identified during an FDA inspection. The product is supplied in 10 mL multiple-dose vials in 10x10 cartons.

Approximately 48,089 cartons were distributed throughout the United States, Puerto Rico, and Canada. The affected batches include lot numbers R2101372, R2101397, R2101404 (expiration 4/30/2023); R2200264, R2200270 (expiration 8/31/2023); R2200382 (expiration 9/30/2023); R2200849 (expiration 12/31/2023); R2201017, R2201138 (expiration 1/31/2024); and R2201249 (expiration 2/29/2024).

Healthcare providers and patients should verify the lot number of products in use or storage against the affected batches listed above. Those with affected product should consult with their supplier or a healthcare provider regarding alternative sources.

The recalled product

Product
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-
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Injectable Pharmaceutical
Hazard
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Batches: R2101372
  • R2101397
  • R2101404
  • Exp. Date 4/30/2023
  • R2200264
  • R2200270
  • Exp. Date 8/31/2023
  • R2200382
  • Exp. Date 9/30/2023
  • R2200849
  • Exp. Date 12/31/2023
  • R2201017
  • R2201138
  • Exp. Date 1/31/2024
  • R2201249
  • Exp. Date 2/29/2024

Distribution

Distribution scope not specified by the agency.

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