CLASS III Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled
Pack Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, (, distributed nationwide in the US. The recall was initiated on 9 Sep 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1072-2014
- FDA event ID
- 66595
- Recalling firm
- Pack Pharmaceuticals, Buffalo Grove, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Sep 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 9 Sep 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +148 days |
| 12 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15.
Where was it sold?
Nationwide and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 66595This product is part of a recall event; the main page for the event is Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Pack Pharmaceuticals
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ofloxacin Ophthalmic Solution, USP 0.3% recalled by PACK Pharmaceuticals | Pack Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5% recalled | Pack Pharmaceuticals | Potency & Assay | Nationwide |
Other Timolol recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |