Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class I - Dangerous
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class I - Dangerous
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class I - Dangerous
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class I - Dangerous
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
Wuhan Bingbing Pharmaceutical Co.
Class I - Dangerous
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
Wuhan Bingbing Pharmaceutical Co.
Class I - Dangerous
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08
Glaxosmithkline Consumer Healthcare Holdings
Class I - Dangerous
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class I - Dangerous
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class I - Dangerous
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
Class I - Dangerous
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
Class I - Dangerous
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
PharMEDium Services
Class I - Dangerous
Firm is recalling 46 lots of various products because of a lack of sterility assurance.