FDA Drug recall D-385-2013
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Ma…
- FDA Drug
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Ma… by Fvs Holdings Dba Green Valley Drugs, citing lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associate….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-385-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fvs Holdings Dba Green Valley Drugs |
| Distribution | US |
Product
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Reason
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.
Identifiers
| code_info | Lot #: a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/3…Lot #: a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013 |
|---|
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-385-2013%22
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