CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4...

FDA Drug Recall #D-1225-2019 — Class II — April 12, 2019

Recall Summary

Recall Number D-1225-2019
Classification Class II — Moderate risk
Date Initiated April 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CMC Enterprise Pharmacy
Location Charlotte, NC
Product Type Drugs
Quantity a) 1357 bags; b) 6895 syringes

Product Description

CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

NC

Lot / Code Information

Lots: a) ED041904 Exp. 4/13/2019; ED051906 Exp. 4/14/2019; ED081905 Exp. 4/17/2019; ED091905 Exp. 4/18/2019; ED111905 Exp. 4/20/2019; b) EB271906 Exp. 4/13/2019; EB281906 Exp. 4/14/2019; EC051906 Exp. 4/19/2019; EC061905 Exp. 4/20/2019; EC071906 Exp. 4/21/2019; EC081907 Exp. 4/22/2019; EC111905 Exp. 4/25/2019; EC121907 Exp. 4/26/2019; EC131905 Exp. 4/27/2019; EC141905 Exp. 4/28/2019; EC151905 Exp. 4/29/2019; EC181906 Exp. 5/2/2019; EC191907 Exp. 5/3/2019; EC201905 Exp. 5/4/2019; EC211906 Exp. 5/5/2019; EC221907 Exp. 5/6/2019; EC251906 Exp. 5/9/2019; EC261906 Exp. 5/10/2019; EC271906 Exp. 5/11/2019; EC281906 Exp. 5/12/2019; EC011904 Exp. 5/16/2019; ED021908 Exp. 5/17/2019; ED031906 Exp. 05/18/2019; ED041905 Exp. 5/19/2019; ED051907 Exp. 5/20/2019; ED081906 Exp. 5/23/2019; ED091905 Exp. 5/24/2019; ED101906 Exp. 5/25/2019; ED111906 Exp. 5/26/2019

Other Recalls from CMC Enterprise Pharmacy

Recall # Classification Product Date
D-1228-2019 Class II Chlorothiazide 100 mg, 3.57 mL syringe, Made by... Apr 12, 2019
D-1209-2019 Class II Dexmedetomidine 400 mcg in NS 100 mL bag, Made ... Apr 12, 2019
D-1214-2019 Class II Magnesium Sulfate 2 GM in NS 50 mL bag, Made by... Apr 12, 2019
D-1226-2019 Class II CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made b... Apr 12, 2019
D-1240-2019 Class II DelNido Cardioplegia (Normosol-R pH 7.4 or Plas... Apr 12, 2019

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.