The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0985-2017·Announced 2017-07-26

PharMedium Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

PharMedium Services is recalling specific lots of Succinylcholine Chloride Injection due to a media fill failure that compromised sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

PharMedium Services, LLC is recalling specific lots of Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use. The recall was initiated due to a lack of assurance of sterility resulting from a media fill failure at the manufacturer.

The affected product is identified by NDC 61553-364-65. The specific lots subject to this recall include 171390026D, 171370064D, 171390027D, 171420074D, 171430062D, 171440058D, 171450001D, 171450002D, and 171450056D. These lots have expiration dates ranging from August 16, 2017, to August 24, 2017.

The product was distributed nationwide. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected product immediately. Consumers should not use this product and should contact their healthcare provider for guidance.

The recalled product

Product
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Manufacturer
PharMedium Services, Llc
Category
Drug — Injectable
Hazard

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 (9)

  • Lots: 171390026D Exp. 08/20/2017
  • 171370064D Exp. 8/16/2017
  • 171390027D Exp. 8/20/2017
  • 171420074D Exp. 8/21/2017
  • 171430062D Exp. 8/22/2017
  • 171440058D Exp. 8/23/2017
  • 171450001D Exp. 8/23/2017
  • 171450002D Exp. 8/23/2017
  • 171450056D Exp. 08/24/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by PharMedium Services, Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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