March 29, 2019
Sterility concerns have prompted Advanced Pharma Inc. to issue recalls for two injectable narcotic pain solutions, according to the March 27, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following hydromorphone and fentanyl products, which were distributed throughout the United States:
- hydromorphone hydrochloride 1 mg in 0.9% sodium chloride, qs 5 mL injectable solution 1 mg/5 mL (0.2 mg per mL), sterile single-use syringes (NDC 42852-289-67), from lots 12/03/18 4090 28967S (Exp. 4/2/19) and 12/03/18 6221 28967S (Exp. 4/2/19);
- fentanyl 1000 mcg/100 mL injectable solution fentanyl 0.9% sodium chloride, qs, 100 mL, sterile single-use bags (NDC 42852-210-10), from lot 01/03/19 1311 21010P (Exp. 5/3/19); and
- fentanyl 2500 mcg/250 ml injectable solution, fentanyl 0.9% sodium chloride, qs, sterile single-use bags (NDC 42852-210-25), from lot 01/03/19 1645 21025P (Exp. 5/3/19).
Advanced Pharma Inc. voluntarily initiated the recalls March 13, 2019. On March 21, 2019, the FDA designated them Class II. The classification suggests use of the affected drugs could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.
Hydromorphone and fentanyl are narcotic analgesics used to manage pain.