Morphine, Fentanyl among drugs recalled after possible contamination
Possible microbial contamniation has led SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) to voluntarily recall all/the following lots of the below listed injectable products to the hospital level.
Officials say administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue, but out of an abundance of caution, is voluntarily initiating this recall.
Product Name Product Number Type of Packaging Indication SCA Lot Number Beyond Use Date Quantity Shipped Date(s) Distributed Succinylcholine Chloride 20 mg/mL 10 mL syringe 70004-0910-
29 Rigid plastic syringe, 10mL Skeletal muscle relaxant 20170726@35 10/24/2017 1248 07/27/2017
– 07/28/2017 Hydromorphone 1 mg/mL in 25 mL 0.9% Sodium Chloride 70004-0303-
17 Rigid plastic syringe, 30mL Analgesic 20170808@52 11/06/2017 128 08/09/2017 Fentanyl 2 mcg/mL + Bupivacaine 0.125% in 250 mL 0.9% Sodium Chloride 70004-0231-
40 Flexible plastic IV bag, 250mL Analgesic 20170814@20 11/12/2017 116 08/16/2017
– 08/25/2017 Hydromorphone 20 mcg/mL + Bupivacaine 0.075% in 50 mL 0.9% Sodium Chloride 70004-0331-
22 Flexible plastic IV bag, 50mL Analgesic 20170816@65 10/30/2017 60 08/18/2017 Morphine 1 mg/mL in 50 mL 0.9% Sodium Chloride 70004-0100-
22 Flexible plastic IV bag, 50mL Analgesic 20170901@25 11/30/2017 238 09/06/2017
– 09/27/2017 Morphine 1 mg/mL in 100 mL 0.9% Sodium Chloride (CADD) 70004-0100-
63 Flexible plastic bag inside
rigid translucent plastic case (CADD), 100mL Analgesic 20170905@24 12/04/2017 60 09/06/2017
– 09/18/2017 Oxytocin 30 units added to 500 mL Lactated Ringers 70004-0086-
44 Flexible plastic IV bag, 500mL Precipitate Labor 20170912@13 10/22/2017 450 09/13/2017
– 09/14/2017 Phenylephrine 100 mcg/mL 10 mL in 12 mL syringe 70004-0810-
12 Rigid plastic syringe, 12mL Hypotension 20170920@53 12/19/2017 1221 09/22/2017
Product Name Product Number Type of Packaging Indication SCA Lot Number Beyond Use Date Quantity Shipped Date(s) Distributed Fentanyl 2 mcg/mL (as citrate) Ropivacaine HCl 0.1% 70004-0264-
64 Flexible plastic bag inside
rigid translucent plastic case (CADD), 100mL Analgesic 20170815@26 11/13/2017 20 08/17/2017 Calcium Gluconate 2 g added to 50 mL 0.9% Sodium Chloride 70004-0510-
30 Flexible plastic IV bag, 50mL Hypocalcemia 20170920@20 11/09/2017 76 9/26/2017 Rocuronium 10 mg/mL 5 mL in 6 mL syringe 70004-850-
09 Rigid plastic syringe, 6mL Skeletal muscle relaxant 20171004@4 01/09/2018 487 10/05/2017
These injectable products’ indicated use and package type are identified in the above table. The affected product lots are also included in the table above. The product can be identified by the attached labels. The products associated with this recall were distributed nationwide to hospitals.
SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals at the address below.
SCA Pharmaceuticals
8821 Knoedl Court Little Rock, AR 72205
Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800- 332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the Food and Drug Administration.
