Class I - Dangerous
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
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.
Teva Pharmaceuticals USA
Class I - Dangerous
Sub-Potent Drug: Out of specification test results for potency (below specification).
Class I - Dangerous
Labeling: Error on Declared Strength
Class I - Dangerous
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I - Dangerous
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Par Pharmaceutical
Class I - Dangerous
Failed Impurity /Degradation Specifications
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.
Class I - Dangerous
Cross Contamination with other products: trace amounts of lidocaine
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
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.
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.
Class I - Dangerous
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Class I - Dangerous
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class I - Dangerous
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
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.
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
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
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.
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
Class I - Dangerous
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.