FDA Drug Recalls

57 recalls, newest first

Nov 22, 2016 Class III · Low risk

Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick

Labeling: Label Mix Up- Incorrect back label applied to the product.

Terminated Labeling / mix-up Les Emballages Knowlton Inc. D-0225-2017

Nov 8, 2016 Class III · Low risk

Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation

Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.

Terminated Labeling / mix-up Care-Tech Laboratories, Inc. NDC 46706-201-01 D-0235-2017

Nov 4, 2016 Class III · Low risk

Amoxicillin for Oral suspension

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Terminated Labeling / mix-up West-Ward Pharmaceuticals Corp. NDC 0143-9887-01 D-0147-2017

Oct 20, 2016 Class III · Low risk

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Terminated Labeling / mix-up CutisPharma, Inc. NDC 65628-070-03 D-0139-2017

Oct 20, 2016 Class III · Low risk

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit

Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL

Terminated Labeling / mix-up CutisPharma, Inc. NDC 65628-070-05 D-0138-2017

Oct 19, 2016 Class III · Low risk

Ceftriaxone for Injection

Labeling: Missing Label

Terminated Labeling / mix-up Sandoz Inc NDC 0409-7332-01 D-0145-2017

Oct 19, 2016 Class III · Low risk

Invokamet (canagliflozin and metformin HCl)

Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.

Terminated Labeling / mix-up Janssen Ortho L.L.C. NDC 50458-543-60 D-0115-2017

Oct 18, 2016 Class III · Low risk

Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".

Terminated Labeling / mix-up GSK Consumer Healthcare NDC 0145-1506-01 D-0142-2017

Oct 12, 2016 Class III · Low risk

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

Terminated Labeling / mix-up Pharm D Solutions, LLC D-0427-2017

Sep 15, 2016 Class III · Low risk

PREMARIN (conjugated estrogen tablets, USP)

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.

Terminated Labeling / mix-up Pfizer Inc. NDC 0046-1104-91 D-1528-2016

Sep 15, 2016 Class III · Low risk

Xanax (Alprazolam)

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).

Terminated Labeling / mix-up Mckesson Packaging Services NDC 63739-669-10 D-1527-2016

Sep 8, 2016 Class III · Low risk

Lansoprazole Delayed-Release Capsules

Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

Terminated Labeling / mix-up Mckesson Packaging Services NDC 63739-0555-10 D-1550-2016

Sep 1, 2016 Class III · Low risk

Mozobil (plerixafor injection)

Labeling: Incorrect or Missing Package Insert

Terminated Labeling / mix-up Sanofi-Aventis U.S. LLC D-0704-2017

Aug 24, 2016 Class II · Moderate risk