April 2014 FDA Recall Drug by P&l Developments, Llc
D-1254-2014 - Subpotent Drug

This Class III drug recall was voluntarily initiated by P&l Developments, Llc on April 14, 2014 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1254-2014

Reason for Recall
Subpotent Drug: Phenylephrine component is subpotent.
Initiated
04-14-2014
Reported
04-30-2014
Quantity
2,500,510 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68018
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
P&L Developments, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-25-2015
Product Description About Product Description
Full technical description of the product.
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170

Batch or Lot Expiration Information

Lot# (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).