The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0632-2018·Announced 2018-04-25

Pharmedium Recalls Vasopressin Injection Due to Manufacturing Deviations

Pharmedium Services, LLC voluntarily recalled 72 bags of Vasopressin Injection due to cGMP deviations. The product was distributed in Massachusetts and Washington.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Pharmedium Services, LLC has voluntarily recalled 72 bags of Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL). The recall was initiated on April 10, 2018, and is classified as Class III by the FDA. The reason for the recall is cited as current Good Manufacturing Practice (cGMP) deviations.

The affected product is identified by Lot 180660057S with an expiration date of June 5, 2018. The recall covers 72 bags that were distributed to Massachusetts and Washington. The recall was initiated by the firm and notified via telephone.

The FDA classifies this as a Class III recall, which means the product is not likely to cause adverse health consequences. The recall status is currently terminated as of January 14, 2020. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above.

The recalled product

Product
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injection
Hazard
Affected units
72

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 (1)

  • Lot: 180660057S Exp. 6/5/2018

Distribution

Distributed in 2 states:

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