Pharm D Solutions Recalls HCG Vials Due to Sterility Concerns
Pharm D Solutions is recalling 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized nationwide due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios.
Plain-English summary
Pharm D Solutions, LLC is recalling 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized (NDC 69699-1711-10). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product was distributed nationwide. Specific lot numbers and discard dates are listed in the recall documentation, including lots 04182018:46, 06072018:65, 05082018:01, and 07282018:20.
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 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,171
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 (4)
- Lot: 04182018:46 Discard by: 10/14/2018
- 06072018:65 Discard by: 12/3/2018
- 05082018:01 Discard by: 11/4/2018
- 07282018:20 Discard by: 1/24/2019
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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