FDA Recall
Terminated
Historical recordClass II
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
by CareFusion 213, LLC
- Reason
- Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01
by Pfizer Inc.
- Reason
- Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent; 22 month stability timepoint
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04
by Hill Dermaceuticals, Inc.
- Reason
- Subpotent; 12 month stability timepoint
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
- Published
- April 3, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.
by Novartis Consumer Health
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
by Hospira Inc.
- Reason
- Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28
by Watson Laboratories Inc
- Reason
- Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
by Watson Laboratories Inc
- Reason
- Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01
by Watson Laboratories Inc
- Reason
- Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
by West-Ward Pharmaceutical Corp.
- Reason
- Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
- Published
- March 27, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
by Fresenius Kabi USA LLC (FK USA)
- Reason
- Labeling: Missing label
- Published
- March 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
by AstraZeneca LP
- Reason
- Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
- Published
- March 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
by AstraZeneca LP
- Reason
- Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
- Published
- March 20, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco.
by Humco Holding Group, Inc
- Reason
- Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
- Published
- March 20, 2013
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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