The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0169-2019·Announced 2018-11-07

Pharm D Solutions Recalls Oxytocin IV Bags Due to Sterility Concerns

Pharm D Solutions is recalling 264 vials of Oxytocin 30 unit in LR 500 mL IV bags nationwide due to a lack of assurance of sterility.

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, and the hazard involves a lack of assurance of sterility in an intravenous medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is voluntarily recalling 264 vials of Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV bags. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is identified by NDC 69699-1203-50. The recall covers specific lots with discard dates ranging from June 13, 2018, to November 20, 2018. The product was distributed nationwide.

Healthcare providers and patients should check their inventory for the affected lot numbers and discard by dates. If the product has already been used, individuals should contact their healthcare provider for guidance.

The recalled product

Product
Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50
Manufacturer
Pharm D Solutions, LLC
Category
Drug — IV Infusion
Hazard
Affected units
264

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 (11)

  • Lot: 03152018:12 Discard by: 6/13/2018
  • 04182018:08 Discard by: 7/17/2018
  • 04302018:94 Discard by: 7/29/2018
  • 03292018:44 Discard by: 6/26/2018
  • 05212018:95 Discard by: 8/19/2018
  • 06142018:46 Discard by: 9/12/2018
  • 05312018:37 Discard by: 8/29/2018
  • 06282018:80 Discard by: 9/26/2018
  • 07312018:12 Discard by: 10/29/2018
  • 07102018:53 Discard by: 10/8/2018
  • 08222018:18 Discard by: 11/20/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, 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 79 products in this recall →

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