Why it was recalled
Lack of sterility assurance.
Product description
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Lot numbers, UPCs & expiration codes
Lots: EB281907 Exp. 4/14/2019; EC011905 Exp. 4/15/2019; EC071907 Exp. 4/21/2019; EC081908 Exp. 4/22/2019; EC131906 Exp. 4/27/2019; EC141906 Exp. 4/28/2019; EC151919 Exp. 4/29/2019; EC181907 Exp. 5/2/2019; EC201906 Exp. 5/4/2019; EC211907 Exp. 5/5/2019; EC221908 Exp. 5/6/2019; EC251907 Exp. 5/9/2019; EC261907 Exp. 5/10/2019; EC271907 Exp. 5/11/2019; EC281907 Exp. 5/12/2019; EC011907 Exp. 5/16/2019; ED021909 Exp. 5/17/2019; ED031907 Exp. 5/18/2019; ED041906 Exp. 5/19/2019; ED051908 Exp. 5/20/2019; ED081907 Exp. 5/23/2019; ED091907 Exp. 5/24/2019
Where it was sold
NC
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-1226-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2019
- FDA report date
- May 1, 2019
- Quantity
- 475 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CMC Enterprise Pharmacy
Original FDA data
Every field from FDA enforcement report D-1226-2019, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 82620
- Address
- 4400 Golf Acres Dr
- Code information
- Lots: EB281907 Exp. 4/14/2019; EC011905 Exp. 4/15/2019; EC071907 Exp. 4/21/2019; EC081908 Exp. 4/22/2019; EC131906 Exp. 4/27/2019; EC141906 Exp. 4/28/2019; EC151919 Exp. 4/29/2019; EC181907 Exp. 5/2/2019; EC201906 Exp. 5/4/2019; EC211907 Exp. 5/5/2019; EC221908 Exp. 5/6/2019; EC251907 Exp. 5/9/2019; EC261907 Exp. 5/10/2019; EC271907 Exp. 5/11/2019; EC281907 Exp. 5/12/2019; EC011907 Exp. 5/16/2019; ED021909 Exp. 5/17/2019; ED031907 Exp. 5/18/2019; ED041906 Exp. 5/19/2019; ED051908 Exp. 5/20/2019; ED081907 Exp. 5/23/2019; ED091907 Exp. 5/24/2019
- Postal code
- 28208-5968
- Report date
- May 1, 2019
- Product type
- Drugs
- Recall number
- D-1226-2019
- Classification
- Class II
- Recalling firm
- CMC Enterprise Pharmacy
- Product quantity
- 475 syringes
- Termination date
- Oct 30, 2019
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Distribution pattern
- NC
- Recall initiation date
- Apr 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2019