RECALL: Injectable Drugs Recalled Due to Potential Contamination

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SCA Pharmaceuticals has recalled several injectable products distributed to both human and veterinary hospitals due to the potential risk for microbial contamination.

SCA Pharmaceuticals, which specializes in sterile compounding, has voluntarily recalled 11 lots of several different injectable products that were distributed to both veterinary and human hospitals. These products are being recalled due to the potential risk for microbial contamination. Administering a contaminated product may lead to serious adverse events, including life-threatening infections.

According to the American Veterinary Medical Association, these recalled products are also used in veterinary medicine, and veterinarians and veterinary hospitals should be advised. The following products are being recalled:

Product Name

Product Number

Type of Packaging

Indication

SCA Lot Number

Beyond Use Date

Quantity Shipped

Date(s) Distributed

Succinylcholine chloride 20 mg/mL in 10-mL syringe

70004-0910-

29

Rigid plastic syringe, 10 mL

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, 30 mL

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, 250 mL

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, 50 mL

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, 50 mL

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), 100 mL

Analgesic

20170905@24

12/04/2017

60

09/06/2017

— 09/18/2017

Oxytocin 30 units added to 500 mL lactated Ringer’s

70004-0086-

44

Flexible plastic IV bag, 500 mL

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, 12 mL

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 hydrochloride 0.1%

70004-0264-

64

Flexible plastic bag inside

rigid translucent plastic case (CADD), 100 mL

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, 50 mL

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, 6 mL

Skeletal muscle relaxant

20171004@4

01/09/2018

487

10/05/2017

SCA Pharmaceuticals has not received any complaints or reports of adverse events related to the recalled products. The company is currently notifying customers by telephone, email, and US mail of the voluntary recall and arranging for the return and replacement of all products.

Customers who have any of the products listed above are being asked to discontinue use immediately and return the product to SCA Pharmaceuticals at the following address:

SCA Pharmaceuticals

8821 Knoedl Court

Little Rock, AR 72205

For any other questions regarding the voluntary recall, customers may call SCA Pharmaceuticals at 877-550-5059.

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