Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIAutologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMethylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMorphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMoxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIBrilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IITrypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPapaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPapaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMoxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIApomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIBuprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIChlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPfizer Inc.Class IIIPREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
- 2016-10-05FDA-DrugMckesson Packaging ServicesClass IIIXanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
- 2016-10-05FDA-DrugPharmatech LLCClass IISenna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IISenexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IIDiocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IIAller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IINinjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IINinjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugPharmatech LLCClass IISennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
- 2016-10-05FDA-DrugUnichem Pharmaceuticals Usa IncClass IIILamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
- 2016-09-28FDA-DrugGenzyme Corporation / Genzyme BiosurgeryClass IIIMozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2016-09-28FDA-DrugReckitt Benckiser LLCClass IIIMucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
- 2016-09-28FDA-DrugLupin LimitedClass IIIEscitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Labeling: Incorrect or Missing Lot and/or Expiration Date
- 2016-09-28FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIIAmoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
- 2016-09-28FDA-DrugSandoz IncClass IIPhenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
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