Prescription Drugs Recalls

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Par Pharmaceutical

Class I - Dangerous

Failed Impurity /Degradation Specifications

Aug 10, 2020 Prescription Drugs View Details →

Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.

SCA Pharmaceuticals

Class I - Dangerous

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Jul 29, 2020 Prescription Drugs Nationwide View Details →

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

Fresenius Kabi USA

Class I - Dangerous

Cross Contamination with other products: trace amounts of lidocaine

Jul 22, 2020 Prescription Drugs Nationwide View Details →

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

BAYSHORE PHARMACEUTICALS

Class I - Dangerous

CGMP Deviations

Aug 19, 2020 Prescription Drugs Nationwide View Details →

Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.

SCA Pharmaceuticals

Class I - Dangerous

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Jul 29, 2020 Prescription Drugs Nationwide View Details →

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.

SCA Pharmaceuticals

Class I - Dangerous

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Jul 29, 2020 Prescription Drugs Nationwide View Details →

Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0

Medichem S.A.

Class I - Dangerous

Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

Jun 24, 2020 Prescription Drugs Nationwide View Details →

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.

Aurobindo Pharma USA

Class I - Dangerous

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

Aug 10, 2020 Prescription Drugs Nationwide View Details →

Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.

Hikma Pharmaceuticals USA

Class I - Dangerous

Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

Aug 14, 2020 Prescription Drugs Nationwide View Details →

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

The Mentholatum Company

Class I - Dangerous

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

Jul 31, 2020 Prescription Drugs Nationwide View Details →

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Hetero Labs Limited (Unit V)

Class I - Dangerous

Failed Tablet/Capsule Specification; complaint of bulging tablet

Aug 6, 2020 Prescription Drugs View Details →

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10

BAYSHORE PHARMACEUTICALS

Class I - Dangerous

CGMP Deviations

Aug 19, 2020 Prescription Drugs Nationwide View Details →

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.

SCA Pharmaceuticals

Class I - Dangerous

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

Jul 29, 2020 Prescription Drugs Nationwide View Details →