Why it was recalled
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Product description
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Lot numbers, UPCs & expiration codes
Lot 62110, exp. date 04/2015
Where it was sold
NJ, OH, TX, LA, and Puerto Rico
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1380-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2014
- FDA report date
- Mar 11, 2015
- Quantity
- 581 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
Original FDA data
Every field from FDA enforcement report F-1380-2015, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70097
- Address
- 369 Bayview Ave
- Code information
- Lot 62110, exp. date 04/2015
- Postal code
- 11701-2801
- Report date
- Mar 11, 2015
- Product type
- Food
- Recall number
- F-1380-2015
- Classification
- Class II
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Product quantity
- 581 units
- Termination date
- May 8, 2017
- Reason for recall
- Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- Distribution pattern
- NJ, OH, TX, LA, and Puerto Rico
- Recall initiation date
- Dec 23, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2015