The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0456-2018·Announced 2018-02-28

Pharmedium Recalls Atropine Sulfate Injection Due to Sterility Concerns

Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug represents a significant health risk consistent with the Severe classification for Class II recalls.

Plain-English summary

Pharmedium Services, LLC is voluntarily recalling Atropine Sulfate Injection in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance for the product.

The recall covers all lots of the medication that are remaining within their expiration dates. The product was distributed nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Atropine Sulfate Injection in all strengths, all doses, and all packaging.
Manufacturer
Pharmedium Services, LLC
Category
Drug — Injectable Medication
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 (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 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 42 products in this recall →

Related recalls

Same manufacturer · Pharmedium Services, LLC

See all →

Same hazard · sterility failure

See all →

Similar recalls