The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0152-2019·Announced 2018-11-07

Pharm D Solutions Recalls Epinephrine Injectable Due to Sterility Concerns

Pharm D Solutions is recalling 945 syringes of Epinephrine 1 mg/1 mL injectable solution 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported in the text, the 'Lack of Assurance of Sterility' for an injectable drug is a significant hazard that aligns with the Severe criteria for Class II recalls involving potential serious harm.

Plain-English summary

Pharm D Solutions, LLC is recalling 945 syringes of Epinephrine 1 mg/1 mL 3 mL Injectable solution. The recall is being conducted because of a lack of assurance of sterility for the product.

The affected product is identified by NDC 69699-0109-03. The specific lots involved are 07272018:17 (Discard by: 9/25/2018) and 08292018:74 (Discard by: 10/28/2018). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The FDA has classified this recall as Class II.

The recalled product

Product
Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
945

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 (2)

  • Lots: 07272018:17 Discard by: 9/25/2018
  • 08292018:74 Discard by: 10/28/2018

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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