Key Takeaway

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 by Hi-Tech Pharmacal Co., Inc. was recalled on December 23, 2014. The hazard: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

FDA Food Class II Terminated

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

Recalled: December 23, 2014 ~581 units units affected F-1380-2015

Description

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Food

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

Food

Company Information

Hi-Tech Pharmacal Co., Inc.

Amityville, NY, United States

View all 10 recalls by Hi-Tech Pharmacal Co., Inc. →

Distribution

NJ, OH, TX, LA, and Puerto Rico

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Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is pac

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Food. Visit the agency's official website for the original notice.

Data sourced from FDA Food Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.