POLYHEXAMETHYLENE BIGUANIDE 0 recalled over sterility concerns
- Recall date
- December 22, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pharmacy Innovations recalls POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th…
- Recall number
- D-0232-2023
- FDA classification
- Class II
- Brand / firm
- Pharmacy Innovations
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Get recall alerts
Free email alert whenever Pharmacy Innovations has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Pharmacy Innovations