FDA MedWatch Safety Alert: Ketorolac Tromethamine Injection by Sagent Pharmaceuticals: Recall – Due to Lack of Sterility Assurance

Sagent Pharmaceuticals, announced the voluntary nationwide recall of Lot Number M813513 of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.  

Share this post

Share on facebook
Share on twitter
Share on linkedin
Share on print
Share on email
Pain Medicine Journal
Access to this page is restricted to members only! Not a mamber? Join Now!

Ask Us Anything. Anytime.

📝 Fill in your details and we’ll get back to you in no time.
AAPM

American Academy of Pain Medicine