Acetylcysteine Injection recall: Sterility Concern
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only…
Why was Acetylcysteine Injection recalled?
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13.
- Product
- Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only…
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Quantity
- 93 vials
- Distribution
- Nationwide
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)