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U.S. Department of Health and Human Services

Enforcement Report - Week of May 7, 2014

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Event Detail

Event ID 68037
Product Type Drugs
Status Ongoing
Recalling Firm P&L Developments, LLC
City Lynwood
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-15
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Nationwide in US

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04. Lot # (expiry): Aaron Health A) 73825 (6/14), 74141 (6/14), 74830 (6/14), 74898 (7/14), 75339 (7/14), 75455 (7/14), 78531 (9/14), 79050 (9/14), 79267 (10/14), 80017 (7/14), 80781 (7/14), 81121 (10/14), 82178 (10/14). FAMILY wellness B) 82312 (10/14), 82500 (10/15), 133197 (1/15), 140385 (1/15), 141937 (2/15), 142669 (2/15), 143201 (2/15), 143656 (2/15), 145268 (2/15), 146058 (2/15), 146406 (2/15), 146963 (2/15), 147613 (3/15), 148105 (3/15), 148297 (7/15), 148809 (3/15), 149149 (8/15), 149317 (8/15), 149411 (8/15), 149814 (8/15), 149815 (8/15), 150305 (8/15), 150673 (8/15), 151039 (9/15), 151573 (9/15), 151762 (9/15), 152798 (9/15), 153206 (9/15), 153207 (9/15), 153514 (9/15), 154024 (9/15), 155380 (1/16). Good Neighbor Pharmacy C)141202 (2/15),145249 (2/15), 146425 (2/15). Pedia Care D) 73242 (5/14), 73243 (5/14), 73244 (5/14), 73824 (6/14), 74206 (6/14), 74207 (6/14), 74303 (6/14), 74460 (6/14), 78805 (9/14), 79265 (10/14), 79266 (10/14), 79573 (9/14), 80456 (6/14), 80457 (7/14), 83746 (1/15), 133196 (1/15), 144273 (2/15), 154090 (9/15). Quality Choice E) 79355 (6/14), 133193 (1/15), 149447 (8/15), 152870 (8/15). Safeway F) 74899 (7/14), 75103 (7/14), 78803 (9/14), 79089 (9/14), 79349 (6/14), 79671 (10/14), 80599 (10/14), 81263 (7/14), 81960 (10/14), 82047 (10/14), 83726 (1/15), 133194 (1/15), 140252 (1/15), 141023 (2/15), 141692 (2/15), 142148 (2/15), 142316 (2/15), 143399 (2/15), 145170 (2/15), 145826 (1/15), 145828 (1/15), 145829 (2/15), 147961 (3/15), 150302 (2/15), 150304 (7/15), 150549 (8/15), 150866 (9/15), 151650 (8/15), 151651 (9/15), 151906 (9/15), 154922 (1/16), 154923 (1/16). Well at Walgreens G) 73671 (5/14), 73898 (6/14), 74459 (6/14), 74900 (7/14), 75306 (7/14), 75671 (7/14), 76022 (7/14), 78804 (9/14), 79264 (5/14), 79325 (6/14), 79747 (6/14), 8188401 (7/14), 8195301 (7/14), 8195401 (9/14), 8195501 (10/14), 8200601 (10/14), 8257301 (10/14), 8282601 (10/14), 8374501 (10/14), 13319201 (1/16), 13319501 (1/16), 14096601 (2/15), 14165601 (2/15), 14193601 (2/15), 14726901 (3/15), 14755501 (3/15), 14812901 (3/15), 14824701 (3/15), 14829601 (7/15), 14914401 (8/15), 15074701 (9/15), 15434701 (11/15). Class III Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. 1,363,338 Bottles D-1298-2014
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