FDA Drug recall D-1071-2014
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10)
- FDA Drug
- Class III
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class III recall of Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10) by Pack Pharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1071-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-09-09 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pack Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot #:NW3071. Exp. 06/15. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1071-2014%22
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