Recalls / Class III
Class IIID-1423-2015
Product
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
- Affected lot / code info
- lot #s 6671801, exp 12/16 and 6706401, exp 7/17
Why it was recalled
Chemical Contamination; benzophenone leached from the product label varnish
Recalling firm
- Firm
- Mutual Pharmaceutical Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1100 Orthodox St, N/A, Philadelphia, Pennsylvania 19124-3168
Distribution
- Quantity
- 5472 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-16
- FDA classified
- 2015-09-09
- Posted by FDA
- 2015-09-16
- Terminated
- 2016-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1423-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.