Class II
Terminated
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
This recall has been terminated (originally issued October 19, 2016).
- Company
- Leiter'S Compounding
- Recall Initiated
- September 20, 2016
- Posted
- October 19, 2016
- Recall Number
- D-0014-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 76,315 total units, all products
- Firm Location
- San Jose, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Distribution
Nationwide
Lot / Code Info
All unexpired lots; Expirations dates of 10/03/2016 to 12/19/2016
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