Class II · Moderate risk Ongoing
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834…
Reason Failed Dissolution Specifications
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for…
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).
What was recalled
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
- Recalling firm
- Torrent Pharma Inc
- NDC code
- 23155-317-51
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1382-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other East recalls
See all
Class II · Moderate risk Ongoing
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals…
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk Ongoing
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason shortfill; reports of empty capsules.
Class II · Moderate risk Ongoing
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
Class I · High risk Ongoing
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…
Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.