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
Out-of-specification results for pH.
See the recall's own reason text for the specifics. All other reasons 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: 22,872 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 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).
Where it was sold
California Florida Idaho Illinois Louisiana Michigan Minnesota North Carolina North Dakota New Jersey New York Ohio Pennsylvania Puerto Rico South Carolina Vermont
FDA's distribution note: CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, 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
- Jul 28, 2014
- In FDA report of
- Dec 28, 2016
- Terminated
- Sep 8, 2017
- FDA recall number
- F-0817-2017 · event 68873
- Official record
- FDA enforcement report search
Other recalls by Hi-Tech Pharmacal Co., Inc.
Rx CHOICE brand LIQUID VITAMIN C
Reason The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.