FDAClass IIMarch 11, 2015

Ferrous Sulfate Elixir 220 Mg/5 Ml recall

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

Why was Ferrous Sulfate Elixir 220 Mg/5 Ml recalled?

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

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 62110, exp. date 04/2015

Product
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Recalling firm
Hi-Tech Pharmacal Co., Inc.
Quantity
581 units
Distribution
NJ, OH, TX, LA, and Puerto Rico
Recall date
March 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (food)
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