Class III · Low risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech…
Reason Failed Impurities/Degradation Specifications
Is Homatropine recalled?
8 FDA recalls mention Homatropine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Homatropine.
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by…
Reason Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class II · Moderate risk Completed
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle…
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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