藥 物 回 收
|
| |
| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple ophthalmic products manufactured and distributed as Altaire labeled products (English only) |
| |
The US Food and Drug Administration (FDA) announces that Altaire Pharmaceuticals, Inc. is voluntarily recalling the over the counter (OTC) and prescription (Rx) drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade. As a precautionary measure, Altaire is voluntarily initiating this recall due to management concerns regarding the sufficiency of quality assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.
This recall is being carried out to the retail level and is only for the specific lots. No other lots are being recalled. A retail level recall is limited to product lots currently in inventory on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products. Altaire further advises as follows:
- To date, Altaire has not received any reports of adverse events for the products.
- To date, Altaire has not obtained any out of specification results, including in-house and third-party sterility testing, for these products.
The affected products are:
- ActivEyes Nighttime Lub Eye Ointment Preservative Free 3.5 g
- Altaire Altacaine Solution 15 mL
- ActivEyes Altachlore Ointment 3.5 gram
- ActivEyes Altachlore Solution 15 mL
- ActivEyes Altalube Ointment 3.5 gram
- Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% 2.5 mL
- Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% 5 mL
- Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% 10 mL
- Altaire Diclofenac Sodium Solution 1% 2.5 mL
- Altaire Diclofenac Sodium Solution 1% 5 mL
- Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution 5 mL
- Altaire Eye Wash 15 mL
- Altaire Eye Wash 1 Fl. Oz.
- Altaire Eye Wash 4 Fl. Oz.
- Altaire Goniotaire 15 mL
- Altaire Homatropaire 5 mL
- NanoTears HA PF Multi Dose Lubricant Gel Drops 10 mL
- Nano Tears MO Clear Emollient Mineral Oil Lipids 10 mL
- Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops 10 mL
- Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack 2 x 10 mL
- Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose 7.5 mL
- Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free 0.6 mL x 32 ct.
- Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free 0.6 mL x 32 ct.
- Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack 2 x 15 mL
- Nano Tears TF Clear Emollient Lubricant Gel Drops 15 mL
- Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack 2 x 10 mL
- Nano Tears XP Clear Emollient Lubricant Gel Drops 10 mL
- Altaire Ofloxacin 0.3% Ophthalmic Solution USP 5 mL
- ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF 7.5 mL
- ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF 7.5 mL
- ActivEyes Lubricant Eye Ointment Preservative Free 3.5 gram
Details of the affected products (including the lot numbers) are available in the FDA website.
The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-manufactured-and
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Jul 17, 2019
Issued at HKT 16:00
|
| |
