Drug Recalls

Washington Homeopathic Products, Inc.

Class II Terminated

Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Reason: cGMP deviations

D-1129-2022 June 22, 2022 Berkeley Springs, WV

Washington Homeopathic Products, Inc.

Class II Terminated

Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Reason: cGMP deviations

D-1141-2022 June 22, 2022 Berkeley Springs, WV

McKesson Corporation dba McKesson Drug Company

Class II Ongoing

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesso...

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

D-0850-2022 May 11, 2022 Memphis, TN

Monarch PCM, LLC

Class III Terminated

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5

Reason: Subpotency: one product for active ingredient assay and another one for preservative assay

D-0818-2021 September 29, 2021 Fort Worth, TX

Monarch PCM, LLC

Class III Terminated

Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in th...

Reason: Subpotency: one product for active ingredient assay and another one for preservative assay

D-0817-2021 September 29, 2021 Fort Worth, TX

Complete Pharmacy and Medical Solutions, LLC.

Class II Terminated

HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, M...

Reason: CGMP deviations: Lack of potency testing.

D-0236-2021 January 27, 2021 Miami Lakes, FL

Complete Pharmacy and Medical Solutions, LLC.

Class II Terminated

HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, M...

Reason: CGMP deviations: Lack of potency testing.

D-0235-2021 January 27, 2021 Miami Lakes, FL

Complete Pharmacy and Medical Solutions, LLC.

Class II Terminated

HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, ...

Reason: CGMP deviations: Lack of potency testing.

D-0234-2021 January 27, 2021 Miami Lakes, FL

Complete Pharmacy and Medical Solutions, LLC.

Class II Terminated

HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, M...

Reason: CGMP deviations: Lack of potency testing.

D-0237-2021 January 27, 2021 Miami Lakes, FL

SCA Pharmaceuticals

Class III Terminated

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

Reason: Subpotency: Out-of-specification stability test result for low potency was obtained.

D-0147-2021 December 23, 2020 Windsor, CT

Teva Pharmaceuticals USA

Class II Terminated

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.

Reason: Sub-Potent Drug: Out of specification test results for potency (below specification).

D-1566-2020 September 16, 2020 Parsippany, NJ

SCA Pharmaceuticals

Class II Terminated

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

D-1495-2020 August 19, 2020 Windsor, CT

SCA Pharmaceuticals

Class II Terminated

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

D-1311-2020 June 24, 2020 Windsor, CT

Taro Pharmaceuticals U.S.A., Inc.

Class I Terminated

Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthor...

Reason: Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

D-0863-2020 March 4, 2020 Hawthorne, NY

B. Braun Medical Inc

Class II Terminated

Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, ND...

Reason: Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP spec...

D-1343-2019 June 19, 2019 Irvine, CA

Advanced Pharma Inc.

Class II Terminated

HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) ...

Reason: Sub-potency

D-1251-2019 May 8, 2019 Houston, TX

King Bio Inc.

Class I Terminated

Dr. King's SafeCare Rx Children's Appetite Enhancer Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC ...