Why it was recalled
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Product description
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Lot numbers, UPCs & expiration codes
Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15
Where it was sold
Nationwide and Puerto Rico
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-1510-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- a) 70,152 bottles; b) 43,525 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
Original FDA data
Every field from FDA enforcement report D-1510-2014, exactly as published.
Show all FDA fields
- City
- Detroit
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 68786
- Address
- 1150 Elijah McCoy Dr
- Code information
- Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15
- Postal code
- 48202-3344
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1510-2014
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Product quantity
- a) 70,152 bottles; b) 43,525 bottles
- Termination date
- Mar 9, 2015
- Reason for recall
- CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 26, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 1, 2014