Pharm D Solutions Recalls Testosterone Cypionate/Proprinate Injectable Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable because of 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, and the rubric specifies that FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk profile consistent with the Severe classification for Class II recalls.
Plain-English summary
Pharm D Solutions, LLC is recalling 580 vials and 30,000 milliliters of Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable (NDC 69699-1745-30). The recall was initiated due to a lack of assurance of sterility.
The affected product was distributed nationwide. The specific lots involved include 02272018:63/A (Discard by 2/22/2019), 08162018:63/A (Discard by 4/30/2019), 10092017:30 (Discard by 10/1/2018), 02272018:63 (Discard by 2/22/2019), and 08162018:63 (Discard by 4/30/2019).
Consumers and healthcare providers should check their inventory for these specific lot numbers and discard by dates. If the product is found, it should be returned to the distributor or the manufacturer for credit.
The recalled product
- Product
- Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable Steroid
- Hazard
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 (5)
- Lot: 02272018:63/A Discard by: 2/22/2019
- 08162018:63/A Discard by: 4/30/2019
- 10092017:30 Discard by: 10/1/2018
- 02272018:63 Discard by: 2/22/2019
- 08162018:63 Discard by: 4/30/2019
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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