FDA Drug recall D-458-2014
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 -…
- FDA Drug
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of 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 -… by Specialty Medicine Compounding Pharmacy, citing 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 th….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-458-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-19 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Specialty Medicine Compounding Pharmacy |
| Distribution | MI |
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 only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Reason
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.
Identifiers
| code_info | All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: a) Injectable 092…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-458-2014%22
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