Recalls / Class II
Class IID-0063-2017
Product
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
- Affected lot / code info
- Lot numbers: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C,151880154M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 5900 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0063-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.