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Wells Pharma of Houston LLC FDA Recalls

8 recalls on file across drugs, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, Class IIApr 1, 2026cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDCClass IIApr 1, 2026cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, Class IIApr 1, 2026cGMP deviations.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03Class IIApr 1, 2026cGMP deviations.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in HoustoClass IIApr 1, 2026cGMP deviations.
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC Class IIApr 1, 2026cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15Class IIApr 1, 2026cGMP deviations.
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells PhClass IINov 22, 2023Lack of assurance of sterility.

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