CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Valsartan, HDPE 90 cc recalled by RemedyRepack
RemedyRepack is recalling Valsartan, HDPE 90 cc, distributed in Florida, Virginia. The recall was initiated on 10 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1101-2018
- FDA event ID
- 80827
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2018
- FDA classified
- 16 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 10 Aug 2018 | Recall initiated by company | |
| 16 Aug 2018 | Classified by FDA | +6 days |
| 22 Aug 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Where it was distributed
Product was distributed to three customers in FL and VA.
Questions about this recall
Is Valsartan, HDPE 90 cc recalled?
Yes. RemedyRepack recalled Valsartan, HDPE 90 cc on 10 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-1101-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lot # B0335344-081717, exp. date 08/2018 Lot # B0363364-110917, exp. date 11/2018 Lot # B0391225-012218, exp. date 01/2019 Lot # B0408458-030618, exp. date 03/2019 Lot # B0384871-010318, exp. date 01/2019 Lot # B0436862-051518, exp. date 05/2019
Where was it sold?
Product was distributed to three customers in FL and VA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq K recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |