Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Drugs Recalls
Prescription and over-the-counter medications
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.
Discoloration and Presence of Foreign Substance
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)
Failed Tablet/Capsule Specification; complaint of bulging tablet
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
CGMP Deviations
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.
Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03
Calvin Scott & Company
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
Calvin Scott & Company
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Ferring Pharmaceuticals
Superpotent Drug
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Ferring Pharmaceuticals
Superpotent Drug
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10
Calvin Scott & Company
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01
Calvin Scott & Company
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
Calvin Scott & Company
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Ferring Pharmaceuticals
Superpotent Drug
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides