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. Out-of-specification results for pH.
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
- Out-of-specification results for pH.
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Firm location
- Amityville, New York, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0817-2017
- Quantity
- 22,872 bottles
- Distribution
- CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico
- Initiated
- 28 July 2014
- Reported by FDA
- 28 December 2016
- Terminated
- 8 September 2017
- Firm notified by
- Letter
- Product codes
- Lot 618283 (Exp. 01/2015), Lot 620151 (Exp. 03/2015), Lot 623407 (Exp. 09/2015) --- EXTENSION: Lots 620915 (Expiry 04/2015), 622298 (Exp. 07/2015), 624881 (Exp. 12/2015), 625981 (Exp. 02/2016), 626967 (Exp. 04/2016), 627676 (Exp. 05/2016).
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 3.1 years, from 28 July 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 15 states, and the FDA published the enforcement report 2.4 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, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Carolina, 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.
| 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. | 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 |
| 2015-03-11 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120. | Class II |
All 3 records for Hi-Tech Pharmacal Co., Inc.
All 2016 recalls · All FDA food recall data
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 accessRecall 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.