Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Cyproheptadine HCl Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Affected NDC
0121-4788-10
Compare with the code on your package — it is the most precise check available.
Drug: Cyproheptadine
- Recalling firm
- Pharmaceutical Associates Inc
- NDC code
- 0121-4788-10
- Origin
- SC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0240-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Cyproheptadine recalls
See all
Class II · Moderate risk
Cyproheptadine Hydrochloride Syrup Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class II · Moderate risk
CYPROHEPTADINE HCL Tablet
Labeling:Label Mixup; CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W003673, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003323, EXP: 6/18/2014.
Other recalls by Pharmaceutical Associates Inc
All 2014 recalls
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent: Out of specification for assay at the 12-month time point.
Class III · Low risk
Nystatin Oral Suspension
Resuspension problems: Out of specification for appearance and resuspendability.
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