Class II · Moderate risk
HydrOXYzine HCI Tablets USP 50 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Cornea Coat
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
- Recalling firm
- Insight Instruments, Inc.
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1056-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other unapproved drug recalls from 2013
All unapproved drug recalls
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 25 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 10 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class I · High risk
Virilis Pro
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
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