Pain Injections Recalled

Potentially defective syringe caps that could affect drug sterility have prompted SCA Pharmaceuticals to recall several fentanyl products. The recalls were included in the January 13, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The following products, which were distributed to hospitals throughout the United States, are under recall:

• fentanyl 100 mcg/50 mL ropivacaine HCl 0.1% in 0.9% sodium chloride 50 mL, 50-mL single-dose syringe (barcode 70004026422), from lots 1220023275 (Beyond Use Date [BUD] 2/15/21), 1220023312 (BUD 2/15/21), 1220023433 (BUD 2/22/21), 1220023515 (BUD 2/24/21), and 1220023671 (BUD 3/1/21);
• fentanyl 100 mcg/50 mL bupivacaine HCl 0.125% in 0.9% sodium chloride 50 mL, 50-mL single-dose syringe (barcode 70004023122), from lots 1220022911 (BUD 1/18/21), 1220023092 (BUD 1/25/21), and 1220023247 (BUD 1/27/21); and
• fentanyl 1500 mcg/30 mL (50 mcg/mL), 30-mL single-dose syringe (barcode 70004020016), from lots 1220022977 (BUD 1/20/21), 1220023122 (BUD 1/25/21), 1220023209 (BUD 1/28/21), 1220023248 (BUD 1/27/21), 1220023319 (BUD 2/1/21), 1220023496 (BUD 2/8/21), and 1220023560 (BUD 2/9/21). 

On December 17, 2020, SCA Pharmaceuticals voluntarily initiated the recall. The FDA designated the recall Class II on January 7, 2021, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Fentanyl is a prescription synthetic opioid pain reliever used to ease severe ongoing pain, such as cancer pain.

—Jolynn Tumolo