Recalls / Class II
Class IID-0687-2017
Product
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
- Affected lot / code info
- Lot Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 11011, 11012, Exp 05/07/17; 11024, 11026, Exp 05/14/17; 11029, Exp 05/16/17; 11030, Exp 05/17/17; 11032, Exp 05/21/17; 11045, Exp 06/04/17; 12008, Exp 06/13/17; 12014, 12015, Exp 06/20/17; 12022, 12024, Exp 06/28/17; 13001, 13002, Exp 07/03/17; 13011, 13012, Exp 07/09/17.
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling firm
- Firm
- Isomeric Pharmacy Solution, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2401 S Foothill Dr Ste D, N/A, Salt Lake City, Utah 84109-1479
Distribution
- Quantity
- 5,165 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-04-06
- FDA classified
- 2017-04-26
- Posted by FDA
- 2017-05-03
- Terminated
- 2017-08-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0687-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.