Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Protein for Undeclared Allergens
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate dietary supplements because FDA inspections found undeclared milk, wheat, and soy.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy."
Plain-English summary
Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate Orange Creamsicle dietary supplements in 2lb and 5lb jugs. The recall was initiated after an FDA inspection revealed that the product contains undeclared milk, wheat, and soy.
The affected products were manufactured by APS Distribution, Inc. and shipped to 43 states, including Alabama, Arizona, California, Florida, Georgia, New York, and Texas. The recall includes all 2lb and 5lb jugs with expiration dates up to and including December 2022.
Consumers with a milk, wheat, or soy allergy should not consume the product. Individuals who have consumed the product and experience allergic reactions should seek medical attention. Consumers can contact Hi Tech Pharmaceuticals for more information regarding the recall.
The recalled product
- Product
- ISOMORPH 28 PURE WHEY iSOLATE ORANGE CREAMSICLE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89856 6 & 5lb, UPC 6 49241 87833 9 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
- Manufacturer
- Hi Tech Pharmaceuticals
- Category
- Food — Dietary Supplement
Distribution
Part of a larger recall action
This product is one of 14 recalled by Hi Tech Pharmaceuticals under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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