Drug Recalls

Failed Dissolution Specifications

Aloe Up Sport Performance Sunscreen Lotion SPF 30

cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.

Ketamine Hydrochloride

Labeling: Incorrect or Missing Lot and/or Exp Date

Hydromorphone HCL PF

Labeling: Incorrect or Missing Lot and/or Exp Date

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

FASENRA (BENRALIZUMAB)

Lack of Assurance of Sterility:

Hand Sanitizer

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Retatrutide

Lack of Assurance of Sterility

SUCCINYLCHOLINE

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Sanifect E3

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Bevacizumab

Lack of assurance of sterility.

CHLORPROMAZINE HYDROCHLORIDE

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

CHLORPROMAZINE HYDROCHLORIDE

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

LEVOTHYROXINE SODIUM

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

NORGESTIMATE AND ETHINYL ESTRADIOL

Failed Content Uniformity Specifications

CHLORPROMAZINE HYDROCHLORIDE

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

CHLORPROMAZINE HYDROCHLORIDE

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

CHLORPROMAZINE HYDROCHLORIDE

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

CARBAMAZEPINE

Failed Dissolution Specifications.

KETOROLAC TROMETHAMINE

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

ENTECAVIR

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

ENTECAVIR

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

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Failed Impurities/Degradation Specifications:

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Failed Impurities/Degradation Specifications:

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Failed Impurities/Degradation Specifications:

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE