Compounded Alprostadil/Papaverine/Phentolamine Injectable Recalled for Sterility Assurance Failure
Tailor Made Compounding recalls two batches of Alprostadil/Papaverine/Phentolamine injectable due to lack of sterility assurance. The recall affects 32 vials distributed nationwide and in Puerto Rico.
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: This is an FDA Class II recall for a sterile injectable product due to lack of assurance of sterility. While no illnesses or injuries have been reported, the potential for serious infection from contamination in an injectable product represents a significant health risk.
Plain-English summary
Tailor Made Compounding is recalling Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL in 3mL vials. Two batches are affected: Batch 01042221A2 (expiration 3/5/2022) and Batch 02192216A1 (expiration 4/20/2022). A total of 32 vials were distributed.
The FDA issued a Class II recall because the manufacturer could not assure that the product maintained sterility during manufacturing. Lack of sterility assurance means the product did not meet required quality standards.
The affected vials were distributed nationwide in the United States and to Puerto Rico.
Patients and healthcare providers should check their medication supply against the recalled batch numbers and expiration dates. Those with affected product should consult their healthcare provider about the recall.
The recalled product
- Product
- Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance-failure
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 (4)
- Batch #: 01042221A2
- Exp 3/5/2022
- 02192216A1
- Exp 4/20/2022.
Distribution
Distributed nationwide across the United States.
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