Recalls / Class II
Class IID-1343-2014
Product
phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02
- Affected lot / code info
- Lot # 13064, 13065, 13066; Exp. 08/18
Why it was recalled
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 14,496 bottles
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2014-04-14
- FDA classified
- 2014-05-21
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-08-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1343-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.