Recalls / Class II
Class IID-0106-2020
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- KRS Global Biotechnology, Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 791 Park of Commerce Blvd Ste 600, N/A, Boca Raton, Florida 33487-3633
Distribution
- Quantity
- 1815 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-09-12
- FDA classified
- 2019-10-01
- Posted by FDA
- 2019-10-09
- Terminated
- 2021-08-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0106-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.