Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Cyproheptadine Hydrochloride Syrup Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
Affected NDC
39328-0044-16
Compare with the code on your package — it is the most precise check available.
Drug: Cyproheptadine
- Recalling firm
- Torrent Pharma Inc
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1358-2019 · 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 III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class II · Moderate risk
Cyproheptadine HCl Syrup
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
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 Torrent Pharma Inc
All 2019 recalls
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
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