Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Acarbose Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
Affected NDC
16252-0523-01
Compare with the code on your package — it is the most precise check available.
Drug: Acarbose
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 16252-523-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1178-2017 · 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 Acarbose recalls
See all
Class II · Moderate risk
Acarbose
Labeling: Label Mixup: ACARBOSE, Tablet, 25 mg may be potentially mislabeled as one of the following drugs: ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: AD60240_57, EXP: 5/22/2014; TOLTERODINE TARTRATE ER, Capsule, 2 mg, NDC 00009519001, Pedigree: W002724, EXP: 6/6/2014; SILDENAFIL CITRATE, Tablet, 25 mg, NDC 00069420030, Pedigree: W003646, EXP: 6/25/2014; SEVELAMER CARBONATE, Tab
Class II · Moderate risk
Acarbose
Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014.
Other recalls by Teva Pharmaceuticals USA
All 2017 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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