Phosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns
Well Care Compounding Pharmacy is recalling 869 vials of Phosphatidylcholine/Deoxycholic Acid due to FDA inspection findings regarding sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are classified as Severe (Score 4), as they carry a risk of serious injury or hospitalization.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Phosphatidylcholine/Deoxycholic Acid 5%/4.75% injection. The product is packaged in 10mL vials and is available by prescription only. The specific lot number is 01252016:44@43, with an expiration date of 07/26/2016.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The lack of assurance of sterility poses a risk to patients who may have received the medication.
The product was distributed in Nevada. Patients who have received this specific lot of medication should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable
- Affected units
- 869
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 #: 01252016:44@43
- Exp. 07/26/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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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