FDA Food EnforcementMedium / 中

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

Recall F-1380-2015Published 2015-03-11Company Hi-Tech Pharmacal Co., Inc.

Reason / 召回原因Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

Distribution / 销售地区NJ, OH, TX, LA, and Puerto Rico

Code information / 批次信息Lot 62110, exp. date 04/2015

Official-information notice / 官方信息说明
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Official record details

官方记录详情：以原始机构公告为准

Recall number / 召回编号

F-1380-2015

Classification / 风险等级

Medium / 中

Published / 发布时间

2015-03-11

Recalling firm / 召回企业

Hi-Tech Pharmacal Co., Inc.

Product description / 产品描述

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701

Product code / 产品代码

Not provided in the official record

Code information / 批次与代码信息

Lot 62110, exp. date 04/2015

Product quantity / 产品数量

581 units

Distribution / 销售地区

NJ, OH, TX, LA, and Puerto Rico

Reason for recall / 召回原因

Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

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