FERROUS SULFATE ELIXIR 220 mg/
Reason Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Rx CHOICE brand LIQUID VITAMIN C recall
Recalled by Hi-Tech Pharmacal Co., Inc. · Amityville, NY, United States
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
A label that does not match the product can hide an ingredient someone must avoid, or show a wrong use-by date. All labeling errors recalls.
What was recalled
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
Quantity: 7692 bottles
Lot codes, dates and UPCs
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
Lot 619618 (Exp. 01/2015)
Where it was sold
California Florida Idaho Illinois Louisiana Michigan North Carolina New Jersey New York Ohio Pennsylvania Puerto Rico Vermont
FDA's distribution note: CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH, PA, VT, and Puerto Rico
Low risk, but check. Class III means the product is unlikely to make anyone ill but breaks an FDA rule, often a labeling one. If your package matches, the store will normally refund it. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Initiated by
- Voluntary: Firm initiated
- Recall initiated
- Aug 25, 2014
- In FDA report of
- Dec 28, 2016
- Terminated
- Sep 8, 2017
- FDA recall number
- F-0820-2017 · event 69095
- Official record
- FDA enforcement report search
Other recalls by Hi-Tech Pharmacal Co., Inc.
Rx CHOICE brand LIQUID VITAMIN C
Reason Out-of-specification results for pH.