Pharm D Solutions Recalls HCG Injectable Due to Sterility Concerns
Pharm D Solutions is recalling HCG Reconstitued 50,000 IU Injectable because the product lacks 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 hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharm D Solutions, LLC is recalling HCG Reconstitued 50,000 IU Injectable (NDC 69699-1736-50). The recall is being conducted because the product lacks assurance of sterility.
The affected product consists of 3 vials per package. The specific lot number is 09062018:07, with a discard-by date of 10/6/2018. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions, LLC for further instructions or a refund.
The recalled product
- Product
- HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 3
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: 09062018:07 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.
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