Recalls / Class II
Class IID-0141-2015
Product
Tetracycline 250 mg powder kits packaged with powder and water in separate amber glass vials, with filter, in bag, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Affected lot / code info
- Lot Number: 07152014@50, Exp 10/13/2014; 07152014@54, Exp 10/13/2014; 07152014@55, Exp 10/13/2014; 07152014@56, Exp 10/13/2014; 07152014@48, Exp 10/13/2014; 07152014@49, Exp 10/13/2014; 08062014@53, Exp 11/4/2014
Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Recalling firm
- Firm
- Martin Avenue Pharmacy, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1247 Rickert Dr, N/A, Naperville, Illinois 60540-1008
Distribution
- Quantity
- 7 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-27
- FDA classified
- 2014-10-29
- Posted by FDA
- 2014-11-05
- Terminated
- 2018-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0141-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.