Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
Reported: June 17, 2020 Initiated: May 19, 2020 #D-1293-2020
Product Description
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
Reason for Recall
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 15,755 cartons
- Distribution
- USA Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11. Recalled by American Health Packaging. Units affected: 15,755 cartons.
Why was this product recalled? ▼
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2020. Severity: Moderate. Recall number: D-1293-2020.
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