Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.
On Feb. 23, 2017, Advanced Pharma, Inc. d/b/a Avella of Houston announced it was voluntarily recalling all unexpired sterile injectable products because products labeled “latex free” may contain synthetic latex and/or natural latex. The recalled products were produced at the company’s Houston, TX location from Sept. 1, 2016–Feb. 16, 2017 and were distributed to healthcare facilities.
While it has not yet received any reports of adverse events, the company is recalling the products out of caution because it cannot be confirmed whether the “latex free” statement is accurate in all cases. According to the company, allergic reactions to latex may include swelling and inflammation and could be life threatening.
The company recommends healthcare facilities discontinue use of the products and return unused portions to Avella Specialty Pharmacy. Adverse events may be reported to FDA at the agency’s website.
Source: FDA