CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalled
KVK-Tech is recalling Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per, distributed nationwide in the US. The recall was initiated on 1 Nov 2019 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-0532-2020
- FDA event ID
- 84184
- Recalling firm
- KVK-Tech, Newtown, PA
- Manufacturer
- KVK-Tech, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2019
- FDA classified
- 29 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 1 Nov 2019 | Recall initiated by company | |
| 20 Nov 2019 | Published in enforcement report | +19 days |
| 29 Nov 2019 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Product as listed by the FDA
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per recalled?
Yes. KVK-Tech recalled Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per on 1 Nov 2019. The recall is Class II and its status is Terminated. Recall number D-0532-2020.
Why was it recalled?
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Which lots are affected?
Lot #: 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Where was it sold?
Nationwide within the United States
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 KVK-Tech
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|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | KVK-Tech | Potency & Assay | Nationwide |
Other Hydrocodone Bitartrate recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen | Ascent Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | KVK-Tech | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen | Lupin Somerset | Labeling Errors | OH |
| Drug | CLASS III | Lupin Hydrocodone Bitartrate recalled by Novel LaboratoriesHydrocodone Bitartrate And Homatropine Methylbromide | Novel Laboratories | Potency & Assay | Nationwide |