Rugby Natural Iron Supplement Recalled for Labeling Error
Advance Pharmaceutical Inc. is recalling Rugby Natural Iron Supplement bottles that contain Meclizine HCl instead of ferrous sulfate due to a label mixup.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Advance Pharmaceutical Inc. is recalling 19,944 bottles of Rugby Natural Iron Supplement, Ferrous Sulfate, 5 gr (325 mg), 100 tablets. The recall is due to a labeling error where the bottles contain Meclizine HCl, a medication indicated for motion sickness, rather than the labeled iron supplement.
The affected product is identified by Lot 12G468 with an expiration date of 07/2014. The product was distributed nationwide. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is being conducted by Advance Pharmaceutical Inc. on behalf of Rugby Laboratories, Inc.
The recalled product
- Product
- Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr (325 mg), 100 TABLETS, Mfd for: RUGBY LABORATORIES, INC. DULUTH, GEORGIA 30097 UPC 0 0536-5890-013
- Manufacturer
- Advance Pharmaceutical Inc
- Category
- Drug — Supplement
- Affected units
- 19,944
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 12G468
- Exp. 07/2014.
Distribution
Distributed nationwide across the United States.
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