Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reported: May 1, 2019 Initiated: April 12, 2019 #D-1212-2019
Product Description
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason for Recall
Lack of sterility assurance.
Details
- Recalling Firm
- CMC Enterprise Pharmacy
- Units Affected
- 6667 syringes
- Distribution
- NC
- Location
- Charlotte, NC
Frequently Asked Questions
What product was recalled? ▼
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.. Recalled by CMC Enterprise Pharmacy. Units affected: 6667 syringes.
Why was this product recalled? ▼
Lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 1, 2019. Severity: Moderate. Recall number: D-1212-2019.
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