Injectable Drug Recalled Due to Sterility Assurance Concerns
An injectable phosphatidylcholine/deoxycholic acid product manufactured by Pharmacy Innovations is being recalled nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
What this means for you
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: FDA Class II recall involving sterility assurance failure in an injectable drug. While no illnesses or injuries have been reported, sterility defects in injectable products represent a high-risk hazard due to potential for serious infection. This meets the criteria of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Innovations is recalling PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID injectable (10mL vials, 50mg/50mg/mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility, following FDA inspection that revealed insanitary conditions at the Erie, Pennsylvania manufacturing facility.
Injectable products require strict sterility standards to prevent microbial contamination and infection. The insanitary facility conditions pose a potential risk of contamination that could affect product safety.
No illnesses or injuries have been reported to date. Patients currently using this product should contact their healthcare provider or pharmacist to discuss whether their specific medication is affected and what alternatives may be available.
The recalled product
- Product
- PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- contamination-risk
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)
- t20221025@32
Distribution
Distributed nationwide across the United States.
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