Reported Aug 13, 2014 · Terminated
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC…
Caraco Pharmaceutical Laboratories, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caraco Pharmaceutical Laboratories, Ltd. · 1150 Elijah McCoy Dr · Detroit, MI · 48202-3344
Is this the product you have?
- Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only
- Manufactured bySun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14 2 AGM0073B, AGM0074B, Exp 04/15 3 AGM0125B, AGM0126B, Exp 07/15 4 AGM0158B, Exp 09/15 5 AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14 6 AGM0067A, AGM0068A, AGM0069A, Exp 03/15 7 AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15 8 AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15 - Amount recalled
- a) 70,152 bottles; b) 43,525 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
This product could cause temporary or reversible health problems — stop using it.
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