PlainRecordsFDA · Drug recall
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose)…
- Date
- Sept. 16, 2015
- Risk class
- Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)
- Status
- Terminated
- Filed by
- Oasis Medical, Inc.
- Product
- ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
- Reason
- Falied pH specification
- Distribution pattern
- FL
- Quantity
- 909 cartons
- Codes and lots
- Lot # V0415F, Exp 10/16
- Recall started
- Aug. 31, 2015
- Recall number
- D-1418-2015
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-1418-2015. The agency record governs; check it and the company before acting.