The Recall Desk
SevereFDA (Drugs)·D-0953-2017·Announced 2017-07-19

Advanced Pharma Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection due to a lack of assurance of sterility. The recall affects 2,350 units distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in an injectable drug) are rated as Severe (4).

Plain-English summary

Advanced Pharma Inc. is recalling QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL, in 5 mL, 7 mL, and 10 mL vials. The recall is being conducted due to a lack of assurance of sterility. The affected product was repackaged by Advanced Pharm in Houston, Texas.

The recall involves 2,350 units of the medication. Specific lot numbers and expiration dates are listed in the official recall notice. The product was distributed nationwide within the United States.

Healthcare providers and patients should stop using the affected lots of QUELICIN and contact Advanced Pharma Inc. for further instructions or to return the product. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
Manufacturer
Advanced Pharma Inc.
Category
Drug — Injectable
Hazard
Affected units
2,350

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 (20)

  • Lot #: a) 5/15/17 2305 81467S
  • BUD 7/29/2017
  • 5/22/17 1000 81467S
  • BUD 8/5/2017
  • 5/30/17 1549 81467S
  • BUD 8/13/2017. b) 5/24/17 0307 169-81479S
  • BUD 7/23/2017
  • 5/18/17 0220 169-81479S
  • BUD 7/17/2017
  • 5/16/17 0306 169-81479S
  • BUD 7/15/2017
  • 6/5/17 0937 169-81479S
  • BUD 8/04/2017
  • 5/16/17 0314 445-81479S
  • 5/16/17 0315 493-81479S
  • c) 5/15/17 2119 81461S
  • 5/22/17 0922 81461S
  • 5/30/17 1533 81461S
  • BUD 8/13/2017
  • 6/12/17 1846 81461S

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Advanced Pharma Inc. 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 4 products in this recall →

Related recalls

Same manufacturer · Advanced Pharma Inc.

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Same hazard · sterility failure

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