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.
Metformin Hydrochloride Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Affected NDC
0591-2720-60
Compare with the code on your package — it is the most precise check available.
Drug: Metformin Category: Diabetes Medication
- Recalling firm
- Actavis Laboratories, FL, Inc.
- NDC code
- 0591-2720-60
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0014-2016 · 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 Actavis Laboratories, FL, Inc.
All 2015 recalls
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
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