Recalls / Class II
Class IID-1029-2013
Product
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
- Affected lot / code info
- Lot # 070213Z, Exp 1/2/2014
Why it was recalled
Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.
Recalling firm
- Firm
- Pharmacy Creations
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 540 Route Ten West, N/A, Randolph, New Jersey 07869
Distribution
- Quantity
- 75 vials
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2013-08-26
- FDA classified
- 2013-09-12
- Posted by FDA
- 2013-09-18
- Terminated
- 2016-04-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1029-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.