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Class II Recall Active for Hydromorphone


May 09, 2019

Advanced Pharma Inc. is recalling 560 bags of hydromorphone 20 mg/100 mL injectable solution, hydromorphone HCl 20 mg 0.9% sodium chloride 100 mL (NDC 42852-221-10), over subpotency concerns, according to the May 8, 2019, US Food and Drug Administration (FDA) Enforcement Report.

The recall affect bags of the compounded drug from lot 01/14/19 0215 22110P (Exp. 04/29/2019). The recalled bags were distributed throughout the United States. 

Advanced Pharma voluntarily issued the recall April 26, 2019. On April 29, 2019, the FDA designated it Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Hydromorphone is a narcotic medication used to relieve pain.  

Jolynn Tumolo

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