Class III · Low risk
Lynparza (olaparib)
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
BRILINTA (ticagrelor)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
Affected NDC
0186-0777-08
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Brilinta Ticagrelor NDC 00186-0777 |
90 mg/1 | Tablet Oral |
AstraZeneca Pharmaceuticals LP | Rx |
- Recalling firm
- AstraZeneca Pharmaceuticals, LP
- NDC code
- 0186-0777-08
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0958-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by AstraZeneca Pharmaceuticals, LP
All 2017 recalls
Class II · Moderate risk
Tudorza Pressair
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Class II · Moderate risk
NEXIUM¿ (esomeprazole magnesium)
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Class II · Moderate risk
Merrem I.V.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Other particulate / foreign matter recalls from 2017
All particulate / foreign matter recalls
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class III · Low risk
Auryxia (ferric citrate)
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
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