Year 2008
2007
2006 2005 2004 2003 2002
U.S. Food & Drug Administration Actions: Recalls and Field Corrections Dietary Supplements -- 1/1/2008 to 4/23/2008
- Sinus & Allergy Nasal Spray, Homeopathic,
- OPTIMUM OYSTER SHELL CALCIUM 250 mg with Vitamin D Dietary Supplement
- Zencore Tabs All Natural Male Enhancement Dietary Supplement and Encore Tabs For Maximum Sexual Performance All Natural Male Enhancement Dietary Supplement
- Folic Acid Liquid, 120 ml
- Protica Nutritional Research Profect Protein Beverage
- Gripe Water All Natural Apple Flavor
March 19, 2008
| PRODUCT |
Sinus & Allergy Nasal Spray, Homeopathic, 0.8 fl. oz; NDC 59853-708-11, Recall # D-171-2008
|
| CODE |
Lot #: 28188W |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Nutraceutical Corporation, Park City, UT, by telephone beginning February 4, 2008.
Manufacturer: Botanical Laboratories, Inc., Ferndale, WA. Firm initiated recall is ongoing.
|
| REASON |
Superpotent; benzalkonium chloride.
|
| VOLUME OF PRODUCT IN COMMERCE |
8,840 bottles |
| DISTRIBUTION |
Nationwide |
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February 27, 2008
| PRODUCT |
OPTIMUM OYSTER SHELL CALCIUM 250 mg with Vitamin D Dietary Supplement, 100 count bottles, Product code 6460-100-01, Recall # D-163-2008
|
| CODE |
Lot # 334830 Expiration 06/08 |
| RECALLING FIRM/MANUFACTURER |
Magno Humphries Inc., Tigard, OR, by letter on February 8, 2008. Firm initiated recall is ongoing.
|
| REASON |
Presence of Foreign Tablet; acetaminophen tablet was found.
|
| VOLUME OF PRODUCT IN COMMERCE |
154 bottles |
| DISTRIBUTION |
OR, WA, MO |
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February 27, 2008
| PRODUCT |
a) Zencore Tabs All Natural Male Enhancement Dietary Supplement, For Maximum
Sexual Performance, packaged in a 2-count blister in a cardboard package, UPC Code
for Individual Packet 859197001013 UPC Code for Display Box 859197001006;
Recall # D-156-2008;
b) Encore Tabs For Maximum Sexual Performance All Natural Male Enhancement
Dietary Supplement, packaged in a 2-count blister in a cardboard package,
UPC Code for Individual Packet 859197001013 UPC Code for Display Box
859197001006; Recall # D-157-2008
|
| CODE |
a) Lot Code: ZT500 (EXP 12/09), ZT010207 (EXP 12/09), ZTS100 (EXP 04/07);
b) Lot Code: 0C85
|
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Bodee LLC, Century City, CA, by press release on August 31, 2007 and November 21, 2007 and letters via e-mail on September 14, 2007 and a 2nd recall letter dated December 7, 2007.
Manufacturer: North West Marketing Co., Inc., Brea, CA. Firm initiated recall is ongoing. |
| REASON |
Unapproved New Drug; product found to contain an undeclared analog of an active ingredient used in a FDA approved product to treat erectile dysfunction.
|
| VOLUME OF PRODUCT IN COMMERCE |
962,627 units. Each unit contains 2 capsules.
|
| DISTRIBUTION |
Nationwide and Internationally
|
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February 20, 2008
| PRODUCT |
Folic Acid Liquid, 120 ml, dietary supplement packaged in a plastic container with dropper. UPC Code 7 66298 00112 8. Foreign Label: Pure encapsulations Reinsubstanzen "Folsaure (flussig)" 120 ml, Recall # F-188-8
|
| CODE |
Lot number 1080507 best by date 05/09
|
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: Pure Encapsulation, Inc., Sudbury, MA, by telephone on November 6, 2007 and November 7, 2007, by email on November 6, 2007 and by letter on November 8, 2007.
Manufacturer: AMT Labs, Inc., N Salt Lake, UT. Firm initiated recall is ongoing. |
| REASON |
Product may be contaminated with mold.
|
| VOLUME OF PRODUCT IN COMMERCE |
1,087 units |
| DISTRIBUTION |
Nationwide, Austria, The Netherland, and UK |
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January 30, 2008
| PRODUCT |
a) Protica Nutritional Research Profect Protein Beverage Grapefruit Mango in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-155-8;
b) Protica Nutritional Research Profect Protein Beverage Fresh Citrus Berry in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-156-8;
c) Protica Nutritional Research Profect Protein Beverage Blue Raspberry Swirl in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-157-8;
d) Protica Nutritional Research Profect Protein Beverage Cool Melon Splash in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-158-8;
e) Protica Nutritional Research Profect Protein Beverage Passion Fruit in 2.9 oz single
serve plastic vial like containers. The product is shipped in cases that contain 12
containers. Recall # F-159-8;
f) Protica Nutritional Research Profect Protein Beverage Ruby Melon Twist in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-160-8;
g) Protica Nutritional Research Profect Protein Beverage Fuzzy Peach Nectar in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-161-8;
h) Protica Nutritional Research Profect Protein Beverage Orange Pineapple in 2.9 oz
single serve plastic vial like containers. The product is shipped in cases that contain
12 containers. Recall # F-162-8
|
| CODE |
Best By 04/01/2009 |
| RECALLING FIRM/MANUFACTURER |
Protica, Inc., Horsham, PA, by e-mail on December 7, 2007. FDA initiated recall is ongoing. |
| REASON |
The products list whey and casein protein as ingredients but do not list milk as the source of the whey and casein as required by Food Allergen Labeling and Consumer Protection Act.
|
| VOLUME OF PRODUCT IN COMMERCE |
19,818 cases (12 containers/case)
|
| DISTRIBUTION |
The product is sold directly to consumers via internet purchasing.
|
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January 23, 2008
| PRODUCT |
The product is packaged in cases of 12/4 oz. plastic bottles; each bottle in a paper board carton. Label information states: Gripe Water All Natural Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups and teething. Dietary Supplement. 4 fl. oz. (120 ml), Recall # F-028-8
|
| CODE |
Unit: 26952V |
| RECALLING FIRM/MANUFACTURER |
Recalling Firm: MOM Enterprises, Inc., San Rafael, CA, by telephone and letter beginning on September 19, 2007.
Manufacturer: Botanical Laboratories Inc., Ferndale, WA. Firm initiated recall is ongoing. |
| REASON |
FDA confirmed through laboratory analysis of this lot of product the presence of cryptosporidium. The product was sampled and tested after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.
|
| VOLUME OF PRODUCT IN COMMERCE |
17,780 bottles |
| DISTRIBUTION |
Nationwide |
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