Pharm D Solutions Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Nandrolone Decanoate 200 mg/mL injectable vials due to a lack of sterility assurance. The recall covers 50 vials distributed nationwide.
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 sterility assurance in an injectable drug, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Pharm D Solutions, LLC is recalling 50 vials of Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only. The recall is being conducted due to a lack of sterility assurance. The affected product is identified by Lot # 01312019:34 with an expiration date of 07/30/2019.
The product was distributed nationwide within the United States. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions at 1-844-263-6846 for further instructions.
The recalled product
- Product
- Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Affected units
- 50
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 #: 01312019:34 Exp. 07/30/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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