The U.S. Food & Drug Administration is alerting consumers to two more eyedrop brand recalls due to potential lack of and non-sterility, that if used, could result in risk of eye infections that could result in blindness.
Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.
Product was distributed worldwide by Purely Soothing LLC via online e-commerce and Trade shows (Ex. Amazon Marketplace, Etc.).
The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation and/or swelling and is packaged in white, cylindrical HDPE bottles. The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids.
Apotex Corp., with the knowledge of the US FDA, is also initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below.
There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.
The six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by NDC numbers stated on the carton and label of the product. The lot number and expiry date are located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode. These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.
Product | Strength | Pack Size | NDC # | UPC Code on Carton |
UPC Code on Bottle |
Lot # | Expiry Date |
---|---|---|---|---|---|---|---|
Brimonidine Tartrate Ophthalmic Solution | 0.15% | 5 mL | 60505-0564-1 | 360505056415 | (01)0(03) 60505056415 |
TJ9848 | 02/2024 |
TJ9849 | |||||||
TK0258 | 04/2024 | ||||||
TK5341 | |||||||
10 mL | 60505-0564-2 | 360505056422 | (01)0(03) 60505056422 |
TK0261 | |||
15 mL | 60505-0564-3 | 360505056439 | (01)0(03) 60505056439 |
TK0262 |
Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight) and is arranging for return of all recalled product.
For more on the Pharmedica USA LLC recall, click here
For more on the Apotex Corp. recall, click here