FDA Recalls For Oct. 30 And Nov. 6, 2013

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

Oct. 30: DRUG – CLASS III
1) Giltuss Antitussive Expectorant and Nasal Decongestant, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08); 2) Exactuss Antitussive Expectorant and Nasal Decongestant, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: Gil Pharmaceutical Corp., Ponce, Puerto Rico.
Code: 1) 1 fl. oz. and 8 fl. oz., batch/lot 615688 (exp. 06/2014) and batch/lot 617689 (exp. 11/2014); 2) 16 fl. oz: batch/lot 615649 (exp. 05/2014).
Manufacturer:	Hi-Tech Pharmacal Co. Inc., Amityville, NY
Recalled by:	Hi-Tech Pharmacal by letter Sept. 4, 2013. Firm-initiated recall is ongoing.
Distribution:	Puerto Rico; 50,848 bottles total among the three 3 lots.
Reason:	Subpotent; phenylephrine HCl.
Recall numbers:	D-66207-001
Ketoconazole Shampoo, 2%, Manufactured by Tolmar Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ -- NDC 0781-7090-04.
Code: Lots: 6111A exp 8/14, 6191A exp 10/14, 5523A exp1/14, 5617A exp 2/14, 5619A exp2/14, 5660A exp 3/14, 5689A exp 3/14, 5690A exp 3/14, 6114A exp 9/14, 6115A exp 9/14,6118A exp 9/14, 6122A exp 9/14, 5307A exp 8/13, 5391A exp 10/13, 5393A exp 10/13, 5392A exp 10/13, 5394A exp 10/13, 5396A exp 11/13, 5430A exp 11/13, 5431A exp 11/13, 5432A exp 11/13, 5434A exp 11/13, 5578A exp 11/13, 5491A exp 11/13, 5492A exp 11/13, 5493A exp 12/13, 5494A exp 12/13, 5531A exp 1/14 5661A exp 3/14, 5490A exp 11/13, 5533A exp 2/14, 5495A exp 12/13, 5534A exp 2/14, 5535A exp 2/14, 5621A exp 2/14, 5728A exp 3/14, 6117A exp 9/14, 6113A exp 9/14, 5776A exp 4/14, 6112A exp 8/14, 6119A exp 9/14, 6192A exp 10/14,and 6123A exp 10/14.
Manufacturer:	Tolmar Inc., Fort Collins, CO.
Recalled by:	Tolmar by letter on Sept. 23, 2013. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 391,055 bottles.
Reason:	Subpotent.
Recall numbers:	D-66402-001
FOOD – CLASS I
NatureMost Laboratories Natural Whey Power W/ Yerba Mate; 1) Vanilla / Almond Dietary Supplement Net Weight 3 lbs. (1,362g). Product Number: 9950; 2) Strawberry / Banana Dietary Supplement Net Weight 3 lbs. (1,362g).
Code: lot #s 1) 9950/3491, 9950/3636, 9950/3766, 9950/4011, 9950/4374, 9950/5025, 9950/5559; 2) 9954/3793, 9954/4043, 9954/4205, 9954/4861.
Manufacturer:	NatureMost of New England Inc., Middletown, CT.
Recalled by:	NatureMost by letter on June 5, 2013. Firm-initiated recall is ongoing.
Distribution:	1) GA, MA, CT, AR, NY, NJ, MD, NH, TX, CA, FL; 370 units; 2) GA, NC, MA, CT, AR, NY, RI, NJ, MN, SC, AZ, OH, MD, IN, NH, TX. St. Thomas, U.S.V.I.; 211 units
Reason:	Undeclared allergens, milk and soy.
Recall numbers:	F-0078-2014, F-0079-2014
1) Vinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, UPC 739930205048; 2) Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, UPC 739930275195; 3) Vinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, UPC 739930205086 (all labeled as distributed by Vinco, Inc., Evans City, PA).
Code: lot #s 1) 11080772 through 11080775, 12040763 through 12040767, 120101069 through 12101073 with expiration dates 10/13 to 2/15; 2) 11060198 through 1106199, 11100897through 1110898, 1204780 through 1204781, 120101089 through 120101090, 13020640 through 13020641 with expiration dates 10/13 to 2/15; 3) 11080560, 11080562, 12100217, 12100218 with expiration dates 10/13 to 2/15.
Manufacturer:	Vinco Inc., Evans City, PA.
Recalled by:	Vinco by letter on June 28, 2013. Firm-initiated recall is ongoing.
Distribution:	Nationwide; N/A.
Reason:	The soy ingredient used to manufacture certain lots of these products potentially was contaminated with salmonella.
Recall numbers:	F-0006-2014, F-0007-2014, F-0008-2014
Nov. 6: FOOD – CLASS III
1) Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm, product 70A; 2) Xylanase150,000XU, powder, enzyme, 100 gm, product 13A; 3) Xylanase10,000XU/g, powder, enzyme, 100 gm, product 45A; 4) Xylanase70,000XU/g, powder, enzyme, 100 gm, product 71A; 5) Nut 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box, product 98A; 6) PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box, product 62A; 7) Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678; 8)EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box, product 73C; 9) EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box, product 77C.
Code: lot #s 1) ALI13157-09; re-evaluation date 12/6/2014; 2) ALI13157-11; re-evaluation date 12/6/2014; 3) ALI13206-05; re-evaluation date 1/25/2015; 4) ALI13206-06; re-evaluation date 1/25/2015 and ALI13008-13; re-evaluation date 7/8/2014; 5) 15 KGS ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS ALI13036-01; re-evaluation date 8/5/2104; 6) 9 KGS, ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS, ALI13024-02; re-evaluation date 7/24/2014; 7) ALI13053-05; re-evaluation date 8/22/2104; 8) ALI13200-09, re-evaluation date 1/19/2015; ALI13140-03, re-evaluation date 11/20/2014; ALI13071-01, re-evaluation date 9/12/2014 and ALI13008-01; re-evaluation date 7/8/2014; 9) ALI13200-08, re-evaluation date 1/19/2015; ALI13140-02, re-evaluation date 11/20/2014; ALI13071-02, re-evaluation date 9/12/2014 and ALI13008-02; re-evaluation date 7/8/2014.
Manufacturer:	American Laboratories Inc., Omaha, NE.
Recalled by:	American Laboratories Inc. by telephone on Sept. 30, 2013. Firm-initiated recall is ongoing.
Distribution:	IA, UT, NV, NE and CA; 1) 1 sample bottle, 100 gm; 2) 1 sample bottle, 100 gm; 3) 1 sample bottle, 100 gm; 4) 2 sample bottles, 100 gm; 5) 1/23 KG-box and 2/15 KG-box; 6) 2/25 KG-boxes and 1 9.4 KG box; 7) 1/25 KG-box 8) 4/5 KG-boxes; 9) 4/5 KG-boxes.
Reason:	The products may be contaminated with chloramphenicol.
Recall numbers:	F-0089-2014; F-0090-2014; F-0091-2014; F-0092-2014; F-0093-2014; F-0094-2014; F-0095-2014; F-0096-2014; F-0097-2014
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.