Nature's Partner Women's Balance, All Natural Paraben Free, 50 mL pump bottle; UPC Code 816726006017. Recall # D-711-2011
CODE
Lot # 050612
RECALLING FIRM/MANUFACTURER
Cosmed Labs Inc., Louisville, KY, by telephone on February 17, 2011. FDA initiated recall is ongoing.
REASON
Misbranded - Labeling bears unapproved therapeutic claims; During an FDA inspection, 2/03/2011 - 03/22/2011, the firm was notified that the product was misbranded due to "structure/function" claims made on the product label, making it an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
183 pump bottles
DISTRIBUTION
TN
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PRODUCT
1) Q-Tussin DM (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-0855-58; UPC 3 0603-0855-58 1. Recall # D-714-2011;
2) CODITUSS DM liquid (Dextromethorphan HBr, USP, 10 mg per 5 mL; Phenylephrine HCl, 5 mg per 5 mL; Pyrilamine Maleate, 8.33 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0728-54; UPC 3 0603-0728-54 0. Recall # D-715-2011;
3) Q-Tapp liquid (Brompheniramine maleate, USP, 1 mg per 5 mL; Dextromethorphan HBr, USP, 5 mg per 5 mL; Pseudoephedrine HCl, USP, 15 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0852-94; UPC 3 0603-0852-94 8. Recall # D-716-2011
4) Iophen DM-NR (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-1330-58; UPC 3 0603-1330-58 2. Recall # D-717-2011
CODE
1) Lot #: L145C10A, L028C10A; Exp 04/12;
2) Lot #: L089C10A, L089C10B, Exp 04/12;
3) Lot #: L090C10A, Exp 04/12;
4) Lot #: L099D10A, L107C10A, L115C10A, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by recall notifications, dated May 5, 2011.
Manufacturer: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL. Firm initiated recall is ongoing.
REASON
CGMP Deviations: These products have been manufactured with a lot of dextromethorphan which was found to be out of specification for an impurity.
VOLUME OF PRODUCT IN COMMERCE
103,718 bottles
DISTRIBUTION
Nationwide
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PRODUCT
Povidone Iodine, USP Prep Solution, 10% Topical Solution, (equivalent to 1% titratable iodine), Antiseptic, First Aid Antiseptic, For Hospital and Professional Use, For external use only, Made in USA, Packaged under the following labels and sizes: (1) NOVAPLUS, a) 4 Fluid Ounces (118 mL), Cat No. V10-8204, NDC 50730-8204-9, b) 16 Fluid Ounces (473 mL), Cat No. V10-8216, NDC 50730-8216-9, c) 32 Fluid Ounces (946 mL), Cat No. V10-8232 NDC 50730-8232-9, d) 128 Fluid Ounces (3.79 L), Cat No. V10-8228, NDC 50730-8228-9; (2) Triadine, a) 4 Fluid Ounces (118 mL), Cat. No. 10-8204, NDC 50730-8204-3, b) 128 Fluid Ounces (3.785 L) Cat. No. 10-8228 / NDC 50730-8228-8; (3) Triad, Triadine Whirlpool Concentrate, Antispetic/Germicide, 128 Fluid Ounces (3.785 L), Cat No. 10-8428, NDC 50730-8428-6; (4) Triad, Plus, a) 2 Fluid Ounces (59 mL), Cat No. 11-LP02, NDC 50730-8202-2, b) 4 Fluid Ounces (118 mL), Cat No. 11-LP04, NDC 50730-8204-3; (5) PSS Select, 1 Gallon (3.785 L). Recall # D-718-2011
CODE
Lot #s: 0H04; 0H07; 0F19; 0K27; Exp 08/13
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by letter dated June 14 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: H & P initiated a recall of 4 lots of Povidone Iodine Solution as a result of stability results showing low active ingredient, Iodine.
VOLUME OF PRODUCT IN COMMERCE
104,280 bottles
DISTRIBUTION
Nationwide, PR, Lebanon, and Trinidad
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PRODUCT
Torsemide tablets, 100 mg, 100-count bottle, Rx only, NDC 31722-532-01. Recall # D-721-2011
CODE
Batch # E100688; Exp 09/12
RECALLING FIRM/MANUFACTURER
Hetero Drugs Limited, Unit-III (Formulations), Hyderabad, IN, by letter dated May 12, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: One lot of torsemide 100 mg tablets 60-count bottle may contain torsemide 10 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
3,900 bottles
DISTRIBUTION
Nationwide and PR
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PRODUCT
The Triad Povidone Iodine Prep Pads in the following Atwater Carey First Aid Kits are being recalled: Atwater Carey, First Aid Kit Personal, 158A, 3 68093 00158 9; Atwater Carey, First Aid Kit Dayhiker, 159A, 3 68093 00159 6; Atwater Carey, First Aid Kit Backpacker , 160A, 3 68093 00160 2; Atwater Carey, First Aid Kit Light & Dry LDI, 273, 3 68093 00273 9; Atwater Carey, First Aid Kit Light & Dry LD2, 274, 3 68093 00274 6; Atwater Carey, First Aid Kit Light & Dry LD3, 275, 3 68093 00275 3; Atwater Carey, Marine First Aid Kit, 299, 3 68093 00299 9. Recall # D-722-2011
CODE
Lot Number (Product Name) 892131 (Personal First Aid Kit) 881573, 901652 (Dayhiker First Aid Kit) 881574, 888918, 890443, 900545 (Backpacker First Aid Kit) 860968, 881490, 884651, 888922, 893091, 900546, 909915 (Light & Dry LD1 Kit) 881577, 888923, 902636, 904134, 908312 (Light & Dry LD2 Kit) 877590, 881578, 886855, 893093, 902635, 902637, 907450, 908311 (Light & Dry LD3 Kit) 888925 (Marine First Aid Kit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wisconsin Pharmacal Company, LLC, Jackson, WI, by letter dated April 14, 2011 and by press release on April 21, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: Wisconsin Pharmacal Company LLC has initiated the recall due to a recall being conducted for the Triad Povidone Iodine Prep Pads manufactured by H&P Industries, Inc. Concerns were expressed by the Food and Drug Administration regarding the potential contamination of Triad Povidone Iodine Prep Pads. The Triad Povidone Iodine Prep Pads are potentially contaminated with an objectionable organism, Elizabethkingia meningoseptica. The Triad Povidone Iodine Prep Pads have an NDC number of 50730-3201-1 and are the only defective material in the First Aid Kits.
VOLUME OF PRODUCT IN COMMERCE
8,521 kits
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
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PRODUCT
G & W Bacitracin Ointment First Aid Antibiotic. Recall # D-713-2011
CODE
Lot # 028009009, Expiration Date July 2011; Lot # 028009006, Expiration Date May 2011
RECALLING FIRM/MANUFACTURER
G & W Laboratories Inc., South Plainfield, NJ, by letters on April 21, 2011. Firm initiated recall is ongoing.
REASON
Stability data does not support exp; failed 18-month stability test for microbiological assay.
VOLUME OF PRODUCT IN COMMERCE
65,376 tubes
DISTRIBUTION
Nationwide
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PRODUCT
1) Bisacodyl delayed-release enteric coated tablets, USP, 5 mg, 100-count bottle, NDC 0603-2483-21, UPC 3 0603-2483-21 1. Recall # D-719-2011;
2) Doc Q Lace (docusate sodium) softgels, 100 mg, 100-count bottle, NDC 0603-0145-21, UPC 3 0603-0145-217. Recall # D-720-2011;
CODE
1) Lot #: J071W, Exp 09/13;
2) Lot #: 103030, 103031, 103033, Exp 02/13; 103032, 104010, 104011, 104012, 104013, 104014, 105015, Exp 03/13; 105011, 105013, Exp 04/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters dated July 11, 2011.
Manufacturers: Time-Cap Laboratories, Inc., Farmingdale, NY;
Swiss Caps USA, Inc., Miami, FL. Firm initiated recall is ongoing. Firm initiated recall is ongoing.
REASON
Labeling: Tablets/Capsule Imprinted W/Wrong I.D.: Incorrect product code printed on products.
VOLUME OF PRODUCT IN COMMERCE
71,400 bottles
DISTRIBUTION
Nationwide and PR
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