L-Glutamine dietary supplement recalled due to unapproved drug claims
Hi-Tech Pharmaceuticals is recalling HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER because the product was marketed with unapproved drug claims. Consumers should stop using the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall for regulatory labeling violation (unapproved drug claims), with no reported safety hazard, contamination, illness, or injury. This is a documentation and marketing compliance issue.
Plain-English summary
Hi-Tech Pharmaceuticals Inc. is recalling HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER (500 grams/17.6 oz), UPC 8 11836 02362 6, Lot 059960809, with expiration date 06/28.
The product was recalled because it was marketed with drug claims that are not FDA-approved. Under FDA law, products making drug claims require FDA drug approval and cannot be marketed as dietary supplements.
The recalled product was distributed nationwide to 50 states and territories, including AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. A total of 85,950 units were affected.
Consumers who have purchased this product should stop using it immediately. For further instructions or to return the product, contact Hi-Tech Pharmaceuticals Inc. at 6015-B Unity Drive, Norcross, GA 30071.
The recalled product
- Product
- HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE ELIMINATION LEAN MUSCLE 500 GRAMS NET WT. (17.630OZ) DIETARY SUPPLEMENT UPC 8 11836 02362 6 HI-TECH PHARMECEUTICALS, INC. 601
- Manufacturer
- Hi-Tech Pharmaceuticals Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- unapproved-drug-claims
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 (1)
- Lot 059960809 Exp Date 06/28
Distribution
Distributed in 50 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- GU
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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