Profarma Recalls 1% Clotrimazol Cream Due to CGMP Deviations
Profarma Distributors LLC recalls 79 boxes of 1% Clotrimazol cream due to Current Good Manufacturing Practice deviations. Check your lot and expiration date.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Profarma Distributors LLC is recalling 79 boxes (79 tubes) of 1% Clotrimazol cream because of Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide. No specific injury or hazard mechanism is described in the record, and no remedy has been provided. Read more at govinfonow.com/recall/42762-profarma-recalls-1-clotrimazol-cream-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42762-profarma-recalls-1-clotrimazol-cream-due-to-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-1043-2016
Cite this page
“Profarma Recalls 1% Clotrimazol Cream Due to CGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42762-profarma-recalls-1-clotrimazol-cream-due-to-cgmp-deviations. Based on FDA recall #D-1043-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1043-2016%22&limit=1).
Why it’s dangerous
The recall is due to deviations from Current Good Manufacturing Practice (CGMP) standards. The record does not specify what these deviations were or how they could affect the safety or efficacy of the cream.
Who’s affected
Consumers who purchased 1% Clotrimazol cream from Profarma Distributors LLC between the manufacturing date and May 11, 2016. It is unclear who is most at risk as the specific nature of the CGMP deviation is not detailed.
How to tell if you have this one
Look for 1% Clotrimazol cream in a 30 mg tube with UPC 501318644335. Check if the lot number is GRU1390 and the expiration date is 08/17.
- Brand
Profarma- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1039-2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057; Lot # 224TS; Exp. 02/17 | 42 boxes (504 capsules) |
| D-1040-2016 | tabcin NOCHE; Capsules,12-count box, UPC 501008485033; Lot # X223FS; Exp. 11/17 | 31 boxes ( 372 capsules) |
| D-1041-2016 | VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619; Lot # UPE187; Exp. 08/17 | 163 boxes (978 tablets) |
| D-1042-2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596; Lot # UJE 040; Exp. 02/17 | 254 boxes (254 tablets) |
| D-1043-2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335; Lot # GRU1390; Exp. 08/17 | 79 boxes (79 tubes) |
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1043-2016 (May 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1043-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.