Recall Number: F-1380-2015
Why was FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 recalled?
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
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City: Amityville
State: New York
Country: United States
Classification: Class II
Classification Date: 2015-03-03
Reason: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Product Description: FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Report Date: 2015-03-11
Product Type: Food
Company: Hi-Tech Pharmacal Co., Inc.
Status: Terminated
Recall Number: F-1380-2015
Postal Code: 11701-2801
Recall Initiation Date: 2014-12-23
Recall End Date: 2017-05-08
Event ID: 70097
Distribution Pattern: NJ, OH, TX, LA, and Puerto Rico
Voluntary Or Mandated: Voluntary: Firm initiated
Initial Firm Notification: Letter
Extra Info: Lot 62110, exp. date 04/2015
Product Quantity: 581 units
Address: 369 Bayview Ave
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