Astral SteriTech Recalls 5 Injections Manufactured for 4 US Clients

Due to a lack of assurance of sterility, Astral SteriTech Private Ltd, Vadodara, India, is recalling 5 different types of injections manufactured for several clients in the United States. The recalls appear in the May 24, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

The recalls affect all unexpired lots of the following products, which were distributed throughout the United States:

• ampicillin for injection manufactured for Piramal Critical Care, Bethlehem, Pennsylvania: 250 mg per vial (NDC 66794-220-41), 500 mg per vial (NDC 66794-221-41), 1 gram per vial (NDC 66794-222-41), 2 grams per vial (NDC 66794-223-41), and 10 grams per pharmacy bulk package (NDC 66794-224-15);
• ampicillin for injection manufactured for Xellia Pharmaceuticals USA, Buffalo Grove, Illinois: 250 mg per vial (NDC 70594-084-02), 500 mg per vial (NDC 70594-085-02), 1 gram per vial (NDC 70594-086-02), 2 grams per vial (NDC 70594-087-02), and 10 grams per pharmacy bulk package (NDC 70594-088-01); 
• ampicillin and sulbactam for injection manufactured for Civica Inc., Lehi, Utah: 1.5 grams per vial (NDC 72572-021-10) and 3 grams per vial (NDC 72572-022-10);
• ampicillin and sulbactam for injection manufactured for Meitheal Pharmaceuticals, Chicago, Illinois: 1.5 grams per vial (NDC 71288-005-20), 3 grams per vial (NDC 71288-006-30), and 15 grams per pharmacy bulk package (NDC 71288-007-75); 
• ampicillin and sulbactam for injection manufactured for Piramal Critical Care: 1.5 grams per vial (NDC 66794-206-41, NDC 66794-241-41), 3 grams per vial (NDC 66794-207-41, NDC 66794-242-41), and 15 grams per pharmacy bulk package (NDC 66794-208-15, NDC 66794-243-15); 
• ampicillin and sulbactam for injection manufactured for Xellia Pharmaceuticals USA: 1.5 grams per vial (NDC 70594-081-02), 3 grams per vial (NDC 70594-082-02), and 15 grams per pharmacy bulk package (NDC 70594-083-01);
• cefepime for injection manufactured for Civica: 1 gram per vial (NDC 72572-057-10) and 2 grams per vial (NDC 72572-058-10); 
• cefepime for injection manufactured for Meitheal Pharmaceuticals: 2 grams per vial (NDC 71288-009-20); 
• cefepime for injection manufactured for Piramal Critical Care: 1 gram per vial (NDC 66794-209-41) and 2 grams per vial (NDC 66794-210-41); 
• cefepime for injection manufactured for Xellia Pharmaceuticals USA: 1 gram per vial (NDC 70594-089-02) and 2 grams per vial (NDC 70594-090-02); 
• ceftriaxone for injection manufactured for Piramal Critical Care: 250 mg per vial (NDC 66794-211-42), 500 mg per vial (NDC 66794-212-42), 1 gram per vial (NDC 66794-213-42), 2 grams per vial (NDC 66794-214-42), and 10 grams per pharmacy bulk package (NDC 66794-215-15); 
• ceftriaxone for injection manufactured for Xellia Pharmaceuticals USA: 250 mg per vial (NDC 70594-094-02), 500 mg per vial (NDC 70594-095-02), 1 gram per vial (NDC 70594-096-02), 2 grams per vial (NDC 70594-097-02), and 10 grams per pharmacy bulk package (NDC 70594-098-01);
• piperacillin and tazobactam for injection manufactured for Civica: 3.375 grams per vial (NDC 72572-576-10) and 4.5 grams per vial (NDC 72572-577-10);
• piperacillin and tazobactam for injection manufactured for Meitheal Pharmaceuticals: 2.25 grams per vial (NDC 71288-002-31), 3.375 grams per vial (NDC 71288-003-31), and 4.5 grams per vial (NDC 71288-004-51);
• piperacillin and tazobactam for injection manufactured for Piramal Critical Care: 2.25 grams per vial (NDC 66794-216-41), 3.375 grams per vial (NDC 66794-217-41), and 4.5 grams per vial (NDC 66794-218-41); and
• piperacillin and tazobactam for injection manufactured for Xellia Pharmaceuticals USA: 2.25 grams per vial (NDC 70594-078-02), 3.375 grams per vial (NDC 70594-079-02), and 4.5 grams per vial (NDC 70594-080-02).

Astral SteriTech voluntarily initiated the recalls May 15, 2023. On May 18, 2023, the FDA designated them Class II. Per the classification, use of the recalled products may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.