FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 62110, exp. date 04/2015
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hi-Tech Pharmacal Co., Inc.
- Reason for Recall:
- Out-of-specification result for pH observed during stability testing of Ferrous Sulfate Elixir, 5 mL unit dose, Lot 621120.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
Product Codes/Lot Numbers:
Lot 62110, exp. date 04/2015
Distribution:
Distributed in: NJ, OH, TX, LA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: F-1380-2015
Related Recalls
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
Hi-Tech Pharmacal Co.
Out-of-specification results for pH.
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
Hi-Tech Pharmacal Co.
The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.