Why it was recalled
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Product description
Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31
Lot numbers, UPCs & expiration codes
Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15, VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16 VCOA011; Exp. 10/16
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-0415-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 25, 2015
- FDA report date
- Mar 25, 2015
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0415-2015, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70592
- Address
- 12 Christopher Way
- Address (line 2)
- Suite 300
- Code information
- Lot # VCOA002; Exp. 09/14, VCOA003; Exp. 10/14, VCOA004; Exp. 10/14 VCOA005; Exp. 01/15, VCOA006; Exp 03/15, VCOA007; Exp 09/15, VCOA008; Exp. 12/15, VCOA009; Exp. 02/16, VCOA010; Exp. 10/16 VCOA011; Exp. 10/16
- Postal code
- 07724-3330
- Report date
- Mar 25, 2015
- Product type
- Drugs
- Recall number
- D-0415-2015
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Termination date
- Feb 26, 2016
- Reason for recall
- Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 25, 2015
- Initial firm notification
- Press Release
- Center classification date
- Mar 17, 2015