Class IITerminated · reported 2015-03-11

FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH…

Hi-Tech Pharmacal Co., Inc. recalled this product and the FDA reported the enforcement action on 11 March 2015 as Class II. The recall was initiated by the firm. Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
UPC: 350838778059
Reason for recall: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Firm location: Amityville, New York, United States
Classification: Class II
Status: Terminated
Recall number: F-1380-2015
Quantity: 581 units
Distribution: NJ, OH, TX, LA, and Puerto Rico
Initiated: 23 December 2014
Reported by FDA: 11 March 2015
Terminated: 8 May 2017
Firm notified by: Letter
Product codes: Lot 62110, exp. date 04/2015

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 2.4 years, from 23 December 2014 to termination on 8 May 2017. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 4 states, and the FDA published the enforcement report 3 months after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: New Jersey, Ohio, Texas, Louisiana. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from Hi-Tech Pharmacal Co., Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

Reported	Product	Firm	Reason	Class
2016-12-28	Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701	Hi-Tech Pharmacal Co., Inc.	Out-of-specification results for pH.	Class III
2016-12-28	Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701	Hi-Tech Pharmacal Co., Inc.	The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.	Class III

All 3 records for Hi-Tech Pharmacal Co., Inc.

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Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.