Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Day Time Cold & Flu
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Phenylephrine component is subpotent.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDCs
41310-0142-06
49035-0142-01
49035-0142-02
49580-3416-01
63868-0245-08
63868-0245-10
63868-0245-12
68013-0142-01
68013-0142-08
68016-0023-79
93351-0142-01
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Childrens Cetirizine Hydrochloride Cetirizine Hydrochloride NDC 68016-0023 |
5 mg/5mL | Solution Oral |
Chain Drug Consortium, LLC (Premier Value) | OTC |
- Recalling firm
- P&L Developments, LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1254-2014 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by P&L Developments, LLC
All 2014 recalls
Class III · Low risk
Nicotine Gum
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Class II · Moderate risk
Cetirizine Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine HCL Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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