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The following medications/products have been recently recalled. Please note that MedStar Family Choice has sent letters to each member affected by these recalls.
On September 8, 2016, Novo Nordisk issued a patient-level recall of Glucagen® Hypokit® for Injection NDC # 00169-7065-15. This recall was issued because a small number of needles were detached from the syringe. A syringe with a detached needle cannot be used as prescribed.
Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen HypoKit. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the United States. It is estimated that out of the 71,215 pens being recalled, four pens could be defective. The affected products were distributed starting February 15, 2016.
The date range for this issue is March 9, 2016 – September 9, 2016.
This recall includes GlucaGen HypoKit lot numbers:
- FS6X270, Exp. 09/30/2017
- FS6X296, Exp. 09/30/2017
- FS6X538, Exp. 09/30/2017
- FS6X597, Exp. 09/30/2017
- FS6X797, Exp. 09/30/2017
- FS6X875, Exp. 09/30/2017
50mm 0.2 Micron Filters manufactured by Baxter Healthcare Corporation
On October 12, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of 50mm 0.2 Micron Filters Product Code H93835 NDC # 17191-0035-00 manufactured by Baxter Healthcare Corporation. This recall affects all unexpired lots and was issued because due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
Diocto Liquid 50 mg/5 mL
On October 19, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I Recall of Diocto Liquid 50 mg/5 mL NDC # 00536-0590-85 manufactured by PharmaTech and distributed by Rugby. This recall was issued due to a risk of product contamination with Burkholderia cepacia. Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. The company learned of the potential issue through the receipt of two isolated complaints regarding this product. FDA has informed PharmaTech and Rugby that it received several adverse event reports of B. cepacia infections in patients. Additionally, some of these reports identify liquid docusate products manufactured by companies other than PharmaTech. The affected lot numbers are as follows:
- 20351407 09/30/16; 20351408 09/30/16
- 20351409 11/30/16; 20351410 12/31/16
- 20351501 01/31/17; 20351502 01/31/17
- 20351503 03/31/17; 20351504 04/30/17
- 20351505 05/31/17; 20351506 06/30/17
- 20351507 06/30/17; 20351508 07/31/17
- 20351509 10/31/17; 20351510 10/31/17
- 20351511 11/30/17; 20351512 11/30/17
- 20351513 11/30/17; 20351601 01/31/18
- 20351602 02/28/18; 20351603 03/31/18
- 20351604 04/30/18; 20351605 04/30/18