Pharm D Solutions Recalls HCG Lyophilized Injectable Due to Sterility Concerns
Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen risk (lack of sterility) for an injectable product, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Pharm D Solutions, LLC is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable (NDC 69699-1707-10) due to a lack of assurance of sterility. The affected product is distributed nationwide.
The recall involves specific lots with discard dates ranging from October 21, 2018, to January 28, 2019. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions or a refund.
The recalled product
- Product
- HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,219
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 (6)
- Lot: 04252018:33 Discard by: 10/21/2018
- 05082018:39 Discard by: 11/4/2018
- 06262018:00 Discard by: 12/23/2018
- 07192018:13 Discard by: 1/15/2019
- 08012018:46 Discard by: 1/28/2019
- 08212018:69 Discard by: 11/30/2018
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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