FDAFDA · Food and drugs·Recall number D-1071-2014
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
Published February 12, 2014 · Recall initiated: September 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PACK Pharmaceuticals, LLC
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #:NW3071. Exp. 06/15.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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