Timolol Maleate Eye Drops Recalled for Exterior Bottle Residue
PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is cosmetic residue on the exterior of the container.
Plain-English summary
PACK Pharmaceuticals, LLC is recalling 122,551 bottles of Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL. 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 revealed white solid product residue on the exterior of the bottles. This residue was identified as dried active ingredients along with the preservative.
The affected lots are NDW3065, NDW3066, NDW3067, NDW3068, and NDW3069, all with an expiration date of 05/15. The products were distributed nationwide and in Puerto Rico. Consumers should check their medication for these lot numbers and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). 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
- Hazard
- Affected units
- 122,551
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 (5)
- Lot #:NDW3065
- NDW3066
- NDW3067
- NDW3068
- NDW3069. Exp.05/15.
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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