Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues
Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling or quality control issue (pH) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 581 units of Ferrous Sulfate Elixir 220 mg/5 mL (NDC 50383-778-05, UPC 350838778059). The recall was initiated after out-of-specification results for pH were observed during stability testing of the product.
The affected product is identified as Lot 62110 with an expiration date of 04/2015. The recall is classified as FDA Class II. The product was distributed in New Jersey, Ohio, Texas, Louisiana, and Puerto Rico.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is precautionary, and no illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Liquid Supplement
- Hazard
- Affected units
- 581
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 62110
- exp. date 04/2015
Distribution
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