Pharm D Solutions Recalls HCG 3000 Unit Powder Due to Sterility Concerns
Pharm D Solutions is recalling 765 vials of HCG 3000 Unit Powder 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 recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Pharm D Solutions, LLC is recalling 765 vials of HCG 3000 Unit Powder (NDC 69699-1738-10) distributed nationwide. The recall was initiated because of a lack of assurance of sterility for the product.
The affected lots are 03262018:79 with a discard by date of 9/22/2018, and 08212018:75 with a discard by date of 2/17/2019. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.
The recalled product
- Product
- HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 765
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)
- Lot: 03262018:79 Discard by: 9/22/2018
- 08212018:75 Discard by: 2/17/2019
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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