0.9% Sodium chloride a) DT-0.9% Sodium chloride* recall: Sterility Concern
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx…
Why was 0.9% Sodium chloride a) DT-0.9% Sodium chloride* recalled?
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
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?
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 09252013@8, 09302013@2, 10152013@6; b) Topical 09252013@9, 09302013@5, 10152013@8
- Product
- 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx…
- Recalling firm
- Specialty Medicine Compounding Pharmacy
- Quantity
- a) Injectable 800 mL; b) Topical 600 mL
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)