Why it was recalled
Chemical Contamination; benzophenone leached from the product label varnish
Product description
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
Lot numbers, UPCs & expiration codes
lot #s 6671801, exp 12/16 and 6706401, exp 7/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1423-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 16, 2015
- FDA report date
- Sep 16, 2015
- Quantity
- 5472 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
Original FDA data
Every field from FDA enforcement report D-1423-2015, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71836
- Address
- 1100 Orthodox St
- Code information
- lot #s 6671801, exp 12/16 and 6706401, exp 7/17
- Postal code
- 19124-3168
- Report date
- Sep 16, 2015
- Product type
- Drugs
- Recall number
- D-1423-2015
- Classification
- Class III
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Product quantity
- 5472 bottles
- Termination date
- Oct 13, 2016
- Reason for recall
- Chemical Contamination; benzophenone leached from the product label varnish
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 16, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 9, 2015