The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0158-2019·Announced 2018-11-07

Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns

Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.

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 injectable drug, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Pharm D Solutions, LLC is recalling HCG Reconstitued 6000 IU Injectable, NDC 69699-1739-06. The recall involves 10-vial packages with Lot 09062018:83 and a discard-by date of 10/6/2018. The product was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the injectable medication is free from microbial contamination.

Consumers and healthcare providers should stop using the affected product immediately. They should contact Pharm D Solutions, LLC for further instructions on how to return or dispose of the recalled vials.

The recalled product

Product
HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
10

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: 09062018:83 Discard by: 10/6/2018

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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