Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH…

Hi-Tech Pharmacal Co., Inc. recalled this product and the FDA reported the enforcement action on 28 December 2016 as Class III. The recall was initiated by the firm. The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.

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

Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701

Reason for recall

The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.

Recalling firm

Hi-Tech Pharmacal Co., Inc.

Firm location

Amityville, New York, United States

Classification

Class III

Status

Terminated

Recall number

F-0820-2017

Quantity

7692 bottles

Distribution

CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH, PA, VT, and Puerto Rico

Initiated

25 August 2014

Reported by FDA

28 December 2016

Terminated

8 September 2017

Firm notified by

Letter

Product codes

Lot 619618 (Exp. 01/2015)

Reading this record

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

• Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 3.0 years, from 25 August 2014 to termination on 8 September 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 12 states, and the FDA published the enforcement report 2.3 years after the firm began the recall.
• Recalls of a dietary supplement run a median of 15 months, so this one was longer than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.

Named in the distribution pattern: California, Florida, Idaho, Illinois, Louisiana, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Vermont. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Filed under dietary supplements. A product can sit in more than one.

Other dietary supplements recalls

These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

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.

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

All 2016 recalls · All FDA food recall data