Sun Pharmaceutical recalls Loteprednol Etabonate Ophthalmic Suspension due to out of specification unit dose content. This may affect eye safety. Contact for details.
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Sun Pharmaceutical is recalling a specific eye drop product because lab tests found the drug concentration is outside acceptable levels. Using this product could lead to eye injury due to the high drug strength.
The eye drop contains a superpotent drug that was found to have incorrect concentration levels. This could cause eye injury if the medication is used as intended.
People with prescriptions for this eye drop are affected. Those with the specific lot numbers and expiration dates listed are most at risk.
Check for the 10 mL or 15 mL bottle with the lot numbers BAC0334A, BAC0532A, BAD0407A, BAD0425A, BAC0335A, BAC0533A, BAD0148A, or BAD0320A. The product is only available by prescription.
Identify the lot number and expiration date on the bottle to confirm if it's in the recalled range.
The product has been found to have incorrect drug concentration levels, which could cause eye injury. Do not use the recalled product.
Check the lot number and expiration date. If it matches the recalled list, stop using it and contact Sun Pharmaceutical for instructions.
Look for the lot numbers BAC0334A, BAC0532A, BAD0407A, BAD0425A, BAC0335A, BAC0533A, BAD0148A, or BAD0320A on the bottle. This product is only available by prescription.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0924-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0924-2023 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
