Drug Recalls

Pharmedium Services, LLC

Class II Terminated

neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

D-0084-2017 October 19, 2016 Lake Forest, IL

Pharmedium Services, LLC

Class II Terminated

ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.

Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

D-0057-2017 October 19, 2016 Lake Forest, IL

Pharmedium Services, LLC

Class II Terminated

lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.

Reason: Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.

D-0067-2017 October 19, 2016 Lake Forest, IL

Lyne Laboratories, Inc.

Class III Terminated

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceutical...

Reason: Subpotency: product assayed and found OOS for cyproheptadine

D-1062-2016 July 13, 2016 Brockton, MA

Pharmakon Pharmaceuticals

Class I Terminated

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

Reason: Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

D-0871-2016 June 1, 2016 Noblesville, IN

Akorn, Inc.

Class III Terminated

IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 1...

Reason: Subpotent Drug: Low out-of-specification potency result of the drug product.

D-1429-2015 September 23, 2015 Lake Forest, IL

Boehringer Ingelheim Roxane Inc

Class II Completed

Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

Reason: Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

D-1085-2015 June 3, 2015 Columbus, OH

Baxter Healthcare Corp.

Class II Terminated

Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL...

Reason: Subpotent Drug: Heparin raw material was found to have low potency

D-0276-2015 December 3, 2014 Deerfield, IL

West-Ward Pharmaceutical Corp.

Class II Terminated

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceuti...

Reason: Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.

D-0172-2015 November 5, 2014 Eatontown, NJ

Independent Nutrition Center, Inc.

Class II Terminated

Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: ...

Reason: Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unappro...

D-1349-2014 May 28, 2014 Eugene, OR

Medisca Inc.

Class I Terminated

Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regula...

Reason: Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

D-1263-2014 May 7, 2014 Irving, TX

Actavis

Class III Terminated

Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Coro...

Reason: Subpotent Drug: Drug potency was compromised during shipment.

D-1088-2014 March 5, 2014 Salt Lake City, UT

IQ Formulations, LLC

Class I Terminated

Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabo...

Reason: Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to...

D-1050-2014 February 5, 2014 Sunrise, FL

Fabscout Entertainment, Inc

Class I Terminated

72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL

Reason: Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil

D-377-2014 December 25, 2013 Ft Lauderdale, FL