FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Reported: March 11, 2015 Initiated: December 23, 2014 #F-1380-2015
Product Description
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Reason for Recall
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Details
- Recalling Firm
- Hi-Tech Pharmacal Co., Inc.
- Units Affected
- 581 units
- Distribution
- NJ, OH, TX, LA, and Puerto Rico
- Location
- Amityville, NY
Frequently Asked Questions
What product was recalled? ▼
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701. Recalled by Hi-Tech Pharmacal Co., Inc.. Units affected: 581 units.
Why was this product recalled? ▼
Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 11, 2015. Severity: Moderate. Recall number: F-1380-2015.
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