Compounding Pharmacy Relents to FDA’s Recall Request

After initially rejecting FDA’s authority over its operations, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns.

Unique Pharmaceuticals voluntarily recalled all of its sterile products on July 19 after a series of FDA inspections questioned the sterility assurance of its products. In its recall, Unique says it hasn’t received any reports of adverse events associated with its sterile compounds, and there is no evidence of contamination in any of the released sterile products.

During a March-to-April inspection of the company’s Temple, Texas, facility, FDA investigators cited numerous violations, including that the company didn’t conduct tests on preservatives used in 16 sterile products at the time of their release, according to a Form 483 issued April 4. The products include lorazepam, dexamethasone and labetalol.

The FDA also chided Unique for not requiring technicians to fully cover their face when working in aseptic processing areas.

During a follow-up June inspection, the FDA cited Unique for poor investigations into sterility failures. Between January and March, the company produced batches of drug products that failed sterility tests, and a batch of neostigmine that failed endotoxin tests, according to the Form 483 issued June 20. The firm “did not document or identify any preventative actions that address lab methods or possible environmental contaminants as a root cause for the failures,” it added.

On July 11, the FDA posted a safety alert warning healthcare professionals to stay away from Unique’s sterile products. The agency also asked the Texas facility to recall its products and cease operations.

But Unique rebuffed that request, noting in a July 14 press release that it did not distribute any sterile drugs that failed sterility tests. Furthermore, there was no evidence that any of the preparations in question failed to meet performance specifications, the company added.

Unique also warned that any recall could affect supplies and potentially lead to drug shortages.

The compounder continues to believe that the products being recalled are safe and sterile. However, it went forward with the recall out of an abundance of caution, spokesman David Shank said.

Unique, which has hired third-party experts to address the concerns, also is temporarily suspending distribution of sterile products to address the FDA’s concerns about alleged sterility issues at the facility. Unique continues to produce non-sterile preparations, Shank said.

The company has voluntarily registered with the FDA under a new regulatory category that means the compounder is subject to agency inspections and must meet its own set of good manufacturing practices.

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