PACK Pharmaceuticals Recalls Timolol Maleate Eye Drops Due to Exterior Residue
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of bottles.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of, or exposure to, the product is not likely to cause adverse health consequences. The issue is cosmetic residue on the exterior of the container.
Plain-English summary
PACK Pharmaceuticals, LLC is recalling 2,022 bottles of Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL (NDC 16571-141-10). The affected products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers with dropper tips and are individually packaged in fiberboard cartons.
The recall was initiated because stability samples of the product showed white solid residue on the exterior of the bottles. This residue was identified as dried active ingredients along with the preservative. The affected lots are NDW3071 and NDW3072, with an expiration date of 06/15.
The products were distributed nationwide and in Puerto Rico. Consumers should check their inventory for these specific lot numbers and expiration dates. If found, they should stop using the product and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). 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.
- Manufacturer
- PACK Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 2,022
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 (2)
- Lot #:NDW3071
- NDW3072. Exp.06/15
Distribution
Part of a larger recall action
This product is one of 6 recalled by PACK Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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