Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc…
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
5 FDA recalls mention Cyproheptadine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyproheptadine.
Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason Subpotency: product assayed and found OOS for cyproheptadine
Reason Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Reason Labeling:Label Mixup; CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree…
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