Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethyle...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1071-2014.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1071-2014.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-D-1071-2014.
PACK Pharmaceuticals, LLC
About the U.S. Food and Drug Administration
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Pack Pharmaceuticals, Llc Recall FAQ
Pack Pharmaceuticals, Llc is the subject of an ophthalmic drugs safety report: Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethyle.... The notice was published on September 9, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 78 units are potentially affected.