Purely Soothing 15% MSM Drops: An official FDA recall notice indicates that this product has yet to be linked to any illnesses or injuries related to Pseudomonas aeruginosa. Its manufacturers have indicated that two lots of this product may not be sterile. These products, made in 1oz and .5oz sizes, can be identified using lot codes and UPC information. Implicated products display the following identifiers: LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9. Improved in-process testing and monitoring to enhance detection of variation during production of each batch. Include remediated in-process quality standards, including but not limited to enhanced sampling, that will more robustly monitor (b)(4) process control. Describe how the improvements will ensure early detection of process variation and manufacturing defects, and prevent consumer exposure to substandard quality drug products.

o Take prompt and appropriate actions for all batches of drug products that contain unacceptable levels of ingredients that could cause them to be harmful, including customer notifications and other applicable market actions for any batches containing harmful ingredients. Detail these actions in your response to this letter. For all batches that you have not conducted 100% visual inspection, conduct 100% visible inspection of your retain samples. If you obtain out-of-specification (OOS) results, conduct investigations and provide your completed investigations, including conclusions and take appropriate market action for all batches of drug products confirmed not meeting specifications.Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms associate with styes, such as:

A: The recommended dose is 2-3 drops per eye 3-4 times a day. Continue use until symptoms diminish. So how do you know if your pink eye is from allergies? Dr. Rapoport says if your symptoms are chronic (i.e., they last over a long period of time, not suddenly), if there is no yellow mucus that comes out, and if the ophthalmologist sees "papillae" or bumps on the inside of the eyelid during an eye exam.

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Your response states that your (b)(4) particle inspection system’s imaging processing, that you qualified in 2022 and utilized for 100% visual inspection, “was too slow” and the rejection rate was too high with “false positive[s]” so you suspended its use and implemented manual visual inspections using AQLs, with no 100% visual inspection. As a corrective action, you planned to re-introduce the (b)(4) system on May 1, 2023. Anisocoria could suggest a life-threatening event due to its association with cranial third-nerve palsy or Horner’s syndrome. Pharmacological mydriasis is one of the benign etiologies of anisiocoria. Although it is common knowledge that the vasoconstrictor in over-the-counter (OTC) eye drops can cause adrenergic mydriasis, 1 there has never been a published report on the pupillary effect from OTC homeopathic eye drops. Not sure which eye drop can handle all your symptoms? We’ve wrapped up the 6 most common eye discomforts into one great formula. Similasan Complete Eye Relief is designed for temporary multi-symptom relief from redness, burning, watering, grittiness, dryness, and irritation. It's okay to use these drops rarely if you need to—however they will not provide long-term allergy relief [and can also] create rebound redness,” explains Dr. Dass.