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Acne Cream Recalled Over Impurities


December 07, 2018

Akorn Inc. is recalling 58,393 jars of clindamycin phosphate topical solution USP, 1% (10 mg/mL clindamycin, NDC 61748-0201-60), because samples tested out-of-specification for impurities. The recall was published in the December 5, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recalled jars, which were manufactured by Ei and distributed across the United States and Puerto Rico, were from the following lots: 2530200 (Exp. 1/31/19), 2530300 (Exp. 1/31/19), 2530400 (Exp. 1/31/19), 2607300 (Exp. 1/31/19), 2607400 (Exp. 1/31/19), 2607500 (Exp. 1/31/19), 2607600 (Exp. 1/31/19), 2615800 (Exp. 1/31/19), 2630200 (Exp. 2/28/19), and 2630300 (Exp. 2/28/19).

Akorn voluntarily initiated the recall October 29, 2018. The FDA had not yet issued a recall classification at the time of the enforcement report. 

Clindamycin phosphate topical solution USP, 1%, is a prescription antibiotic used to treat acne.

Jolynn Tumolo


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