Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Time-Cap Labs (Metformin Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50
Affected NDCs
49483-0623-01
49483-0623-09
49483-0623-10
49483-0623-50
Compare with the code on your package — it is the most precise check available.
Drug: Metformin Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Metformin Hydrochloride Extended Release Metformin Hydrochloride NDC 49483-0623 |
500 mg/1 | Tablet, Extended Release Oral |
Time Cap Laboratories, INC | Rx |
- Recalling firm
- Marksans Pharma Limited
- NDC code
- 49483-623-09
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Oct 2, 2020 · FDA notice with lot numbers
- FDA recall number
- D-0061-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Metformin recalls
See all
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets 1000mg
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended- Release 500mg
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Other recalls by Marksans Pharma Limited
All 2020 recalls
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Time-Cap Labs
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.