CLASS II Drug recall · Reported 29 Jun 2016 · FDA Enforcement Report
tabcin Active M.R recalled by Profarma Distributors
Profarma Distributors is recalling tabcin Active M.R, distributed nationwide in the US. The recall was initiated on 11 May 2016 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-1039-2016
- FDA event ID
- 74135
- Recalling firm
- Profarma Distributors, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2016
- FDA classified
- 17 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 11 May 2016 | Recall initiated by company | |
| 17 Jun 2016 | Classified by FDA | +37 days |
| 29 Jun 2016 | Published in enforcement report | +12 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
Product as listed by the FDA
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
Where it was distributed
Nationwide
Questions about this recall
Is tabcin Active M.R recalled?
Yes. Profarma Distributors recalled tabcin Active M.R on 11 May 2016. The recall is Class II and its status is Terminated. Recall number D-1039-2016.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # 224TS; Exp. 02/17
Where was it sold?
Nationwide
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 Profarma Distributors
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | tabcin Noche recalled by Profarma Distributors | Profarma Distributors | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vermox Tablets 100 mg recalled by Profarma Distributors | Profarma Distributors | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vermox Tablets 500 mg recalled by Profarma Distributors | Profarma Distributors | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | 1% Clotrimazol cream, 30 mg tube recalled by Profarma Distributors | Profarma Distributors | Manufacturing (CGMP) Deviations | Nationwide |