Timolol Maleate Sterile Ophthalmic Solution — Class III drug recall D-1070-2014
Terminated recall by PACK Pharmaceuticals, LLC, reported 2014-02-12, distributed nationwide. Defective Container: Stability samples of both products were noted to have some white solid product residue, i
| Recall number | D-1070-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PACK Pharmaceuticals, LLC, Buffalo Grove, IL, United States |
| Recall initiated | 2013-09-09 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,415 bottles |
| Reason classes | specification failure, packaging |
| NDC | 16571-0140-50 |
| Lot numbers | 05/15, NW3061, NW3062 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1070-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.