12 FDA recalls mention Atlantic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atlantic.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry)…
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an…
Reason Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL)…
Reason Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Reason Failed Impurity/Degradation Specification; "Related Compound C"
Reason Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Reason Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Reason Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Reason Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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