Food product
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
F-1380-2015
Product summary
- Event
- Event 70097
- Status
- Terminated
- Classification
- Class II
- Quantity
- 581 units
- Official record key
food-enforcement:F-1380-2015
Official wording
Reason: Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Code information: Lot 62110, exp. date 04/2015
Distribution pattern: NJ, OH, TX, LA, and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-specification