Contraceptive Injection Recalled

Concerns about product sterility have prompted Sun Pharmaceutical Industries Inc to recall more than 2 dozen lots of medroxyprogesterone acetate distributed by multiple firms throughout the United States.

The recall was included in the June 22, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Sun Pharmaceutical Industries, Ltd, Gujarat, India:

• medroxyprogesterone acetate injectable suspension, 1-mL prefilled syringe (NDC 50102-591-40), 150 mg/mL, from lots JKX4312A and JKX4313A (Exp. 9/22), HAC1290A and HAC2082B (Exp. 6/23), and JKX4827A (Exp. 9/23), distributed by Afaxys Pharma LLC, Charleston, SC;
• medroxyprogesterone acetate injectable suspension, 1-mL prefilled syringe (NDC 16714-999-01), 150 mg/mL, from lots HAC1289A (Exp. 6/23), JKX2679A (Exp. 6/22), JKX3762A (Exp. 8/22), and HAC0164A (Exp. 6/23), manufactured for Northstar Rx LLC, Memphis, TN;
• medroxyprogesterone acetate injectable suspension, 1-mL single-dose vial (NDC 16714-981-01), 150 mg/mL, from lots HAC2075A (Exp. 6/23), HAC2076A (Exp. 7/23), HAC2077A and HAC2078A (Exp. 8/23), HAC3803A (Exp. 9/23), HAC0551A (Exp. 2/23), HAC0562A and HAC1183A (Exp. 3/23), HAC1807A (Exp. 6/23), JKX6017A and JKX6018A (Exp. 12/22), HAC0163A (Exp. 1/23), HAC1184A (Exp. 4/23), and HAC0162A (Exp. 12/22), manufactured for Northstar Rx;
• medroxyprogesterone acetate injectable suspension, 1-mL prefilled syringe (NDC 62756-091-40), 150 mg/mL, from lot HAC1951A (Exp. 6/23), distributed by Sun Pharmaceutical Industries Inc., Cranbury, NJ; and
• medroxyprogesterone acetate injectable suspension, 1-mL single-dose vials packaged in 25-count cartons (NDC 16714-090-40), 150 mg/mL, from lots HAC2074A (Exp. 6/23), HAC0163B (Exp. 1/23), and HAC1741A (Exp. 4/23), distributed by Sun Pharmaceutical Industries.

Sun Pharmaceutical Industries voluntarily initiated the recall May 6, 2022. On June 10, 2022, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Medroxyprogesterone acetate is a prescription contraceptive injection.