Class II · ModerateRecall completed
Clarithromycin Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016; Lot #: LN10488, Expiry: 1/31/2016; Lot #: LN10489, Expiry: 2/29/2016; Lot #: LN10578, Expiry: 2/29/2016; Lot #: LN10581, Expiry: 2/29/2016; Lot #: LN10582, Expiry: 2/29/2016; Lot #: LN11068, Expiry: 4/30/2016; Lot #: LN11073, Expiry: 4/30/2016; Lot #: LN11125, Expiry: 5/31/2016; Lot #: LN11362, Expiry: 8/31/2016; Lot #: LN11379, Expiry: 8/31/2016; Lot #: LN11380, Expiry: 8/31/2016.
Where it was soldU.S. Nationwide including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Firm did not adequately investigate customer complaints.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byWockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA foreign manufacturer
| Distributed by / for | Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA |
| NDC | 64679-949-01 |
Show the full FDA record
| Full product label | Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01. |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | U.S. Nationwide including Puerto Rico. |
| Quantity | 59,729 Bottles |
| Recall initiated | 2015-04-22 |
| Report date | 2015-07-29 |
| Recall completed | 2018-05-09 |
| Recall number | D-1249-2015 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.