Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Reported: July 15, 2015 Initiated: June 1, 2015 #D-1222-2015
Product Description
Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 838 cartons
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.. Recalled by American Health Packaging. Units affected: 838 cartons.
Why was this product recalled? ▼
CGMP Deviations: Firm did not adequately investigate customer complaints.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2015. Severity: Moderate. Recall number: D-1222-2015.
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