FDA (Drugs) recall action 82620
The FDA (Drugs) publishes a recall like this one as 32 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 32 pages.
Lack of sterility assurance.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CMC Enterprise Pharmacy is recalling 705 syringes of Lidocaine Buffered with J-Tip due to a lack of sterility assurance. The products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 97 syringes of Alteplase 1 mg/mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 6,667 Labetalol syringes due to a lack of sterility assurance. The affected products were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 1,310 syringes of Phenylephrine 0.8 mg/10 mL NS due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 40 syringes of Sodium Citrate 4% due to a lack of sterility assurance. The affected lots were distributed in North Carolina.
CMC Enterprise Pharmacy is recalling 118 bags of Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL due to lack of sterility assurance.
CMC Enterprise Pharmacy is recalling 390 bags of Phenylephrine 20 mg NS 250 mL due to a lack of sterility assurance. The affected lots were distributed in North Carolina.