SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination.
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.
To view the original RECALL on the FDA website click here.
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