Pine Pharmaceuticals Announces Recalls, Including Avastin

In response to a recent inspection by the U.S. FDA, Pine Pharmaceuticals has issued two voluntary recalls, including repackaged Avastin and other ocular use products. The company emphasizes that there have been no reported adverse events associated with the impacted products.

Sterility Concerns and Production Adjustments

The inspection, which prompted these recalls, revealed a potential concern related to sterility assurance for repackaged Avastin when produced with specific equipment utilized in select fill lines. Pine Pharmaceuticals swiftly shifted production to unaffected lines, and they anticipate that any product shortages will be temporary.

However, to ensure the availability of these essential products, Pine Pharmaceuticals is requesting that customers place orders for a week’s supply at a time, and they may need to implement allocation limits as deemed necessary.

Additionally, Pine Pharmaceuticals announced that customers using item #987 (Norm-Ject® Less Fill, silicone-free syringe) will need to select an alternative syringe. The temporary unavailability of this product is due to process limitations and will be addressed accordingly.

Information on Impacted Lots and Returns

For comprehensive details about the recall, including impacted lot numbers and instructions for product returns, please refer to the following resources:

1. Recall #1

2. Recall #1 Customer Letter

3. Recall #2

4. Recall #2 Customer Letter

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