Why it was recalled
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Product description
CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
Lot numbers, UPCs & expiration codes
Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)
Where it was sold
Distributed in Georgia and Missouri.
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-0237-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 22, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 340 capsules (17 bottles containing 20 capsules each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-0237-2015, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 69597
- Address
- 12515 E 55th St Ste 106
- Code information
- Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)
- Postal code
- 74146-6234
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0237-2015
- Classification
- Class II
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 340 capsules (17 bottles containing 20 capsules each)
- Termination date
- Mar 16, 2015
- Reason for recall
- CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
- Distribution pattern
- Distributed in Georgia and Missouri.
- Recall initiation date
- Sep 22, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2014