Timolol Maleate Sterile Ophthalmic Solution
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.
Recall notice
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.
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We’re still writing up this recall
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/46618-pack-pharmaceuticals-llc-recalls-timolol-maleate-sterile-ophthalmic-solution-usp · Recall date September 9, 2013 · FDA enforcement record: FDA #D-1073-2014
Cite this page
“Timolol Maleate Sterile Ophthalmic Solution.” GovInfoNow, recall dated September 9, 2013. https://govinfonow.com/recall/46618-pack-pharmaceuticals-llc-recalls-timolol-maleate-sterile-ophthalmic-solution-usp. Based on FDA recall #D-1073-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1073-2014%22&limit=1).
How to tell if you have this one
- Brand
PACK Pharmaceuticals, LLC- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1068-2014 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). 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.; Lot #:OW3061,OW3062. Exp. 05/15. | 32,029 bottles |
| D-1069-2014 | Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). 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.; Lot #:OW3071.Exp. 06/2015. | 126 bottles |
| D-1070-2014 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). 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.; Lot #: NW3061,NW3062. Exp. 05/15. | 3,415 bottles |
| 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.; Lot #:NW3071. Exp. 06/15. | 78 bottles |
| D-1072-2014 | 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.; Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15. | 122,551 bottles |
| D-1073-2014 | 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.; Lot #:NDW3071,NDW3072. Exp.06/15 | 2,022 bottles |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1073-2014 (September 9, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1073-2014 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.